(271 days)
Not Found
No
The summary describes a digital therapeutic delivering a fixed, structured therapy (CBT-I) via a mobile application. There is no mention of the device adapting its behavior or making decisions based on patient data using AI/ML algorithms. The clinical studies evaluate the efficacy of the therapy itself, not the performance of an AI/ML component.
Yes
The product is explicitly stated as a "digital therapeutic" intended to treat chronic insomnia by improving symptoms and providing a neurobehavioral intervention (CBT-I). This directly indicates a therapeutic purpose.
No.
Somryst is described as a "digital therapeutic" intended to provide a neurobehavioral intervention (CBT-I) to treat chronic insomnia. Its purpose is to deliver therapy and improve symptoms, not to diagnose a condition. While it monitors patient utilization and engagement, this is for therapeutic management rather than diagnosis.
Yes
The device is described as a "prescription digital therapeutic (computerized behavioral therapy)" delivered via a "mobile application intended to be used on a patient's mobile device." The description focuses entirely on the software-based delivery of CBT-I and does not mention any accompanying hardware components that are part of the medical device itself. While it runs on a mobile device, the mobile device is the platform, not the medical device hardware.
Based on the provided information, Somryst is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: Somryst's intended use is to provide a neurobehavioral intervention (CBT-I) to treat chronic insomnia. This is a therapeutic intervention delivered through a digital platform, not a diagnostic test performed on biological samples.
- Device Description: The description clearly states that Somryst is a "prescription digital therapeutic" that delivers behavioral therapy. It does not mention any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases based on laboratory results
Somryst is a digital therapeutic that provides behavioral therapy, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chromic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.
Product codes (comma separated list FDA assigned to the subject device)
QVO, PWE
Device Description
Somryst is a 9-week prescription digital therapeutic (computerized behavioral therapy) used in the treatment of chronic insomnia. Somryst is based on principles of Cognitive Behavioral Therapy (CBT) for Insomnia, Sleep Restriction, and other proven psychosocial treatment elements, which are delivered in a sequence of "cores" of patient education, training and skill building. The therapy is delivered via a mobile application intended to be used on a patient's mobile device and consists of text, video, animation and graphics. Clinicians, as part of a patient's general treatment program, have access to a clinician dashboard that shows patient utilization and engagement with the application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
22 years of age and older
Intended User / Care Setting
Patients, Licensed healthcare providers (physicians, practitioners, psychologists, and registered nurses)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A responsive browser-based equivalent to Somryst ("SHUTi") was evaluated in "The GoodNight Study: Prevention of Depression Through Internet-based Insomnia Treatment", a large-scale, randomized controlled trial (ACTRN12611000121965) sponsored by the National Health and Medical Research Council (NHMRC). This trial was performed by the Australian National University in collaboration with investigators at the Black Dog Institute, University of Sydney, and University of Virginia. The main objective of the study was to evaluate the efficacy of a web-based insomnia intervention, Sleep Healthy Using the Internet (SHUTi) for treatment of patients with chronic insomnia against a control arm of Usual Care (UC) and an attention-matched control (HealthWatch).
All study participants received usual care (UC) consisting of behavioral treatment, pharmacotherapy and/or self-treatment (e.g. visit to a general practitioner for sleep and/or mood problems, pharmacotherapy (e.g. for sleep and/or mood problems), over-the-counter sleep aids, visit to a sleep specialist, visit to a mental health provider).
Participants were randomized 1:1 to 9 weeks of treatment with the following:
- UC+SHUTi: Usual Care + SHUTi (now known as SomrystTM)
- UC+Control: Usual Care + Attention-matched, Digital Control
The Digital Control intervention (HealthWatch) was an interactive health and lifestyle web program that contained information about a range of health content (e.g., environmental health, nutrition, activity, medication) but had no specific mental health or sleep-related content. HealthWatch also administered weekly surveys on these topics to match for interaction required in the treatment group.
Participants in the UC+SHUTi group (n=574) were asked to complete all six Cores within the 9-week treatment period. Participants randomized to UC+Control (n=575) were asked to complete nine internet-delivered modules within the 9-week treatment program, thus matching the attention components of SHUTi. Insomnia symptoms were evaluated for all participants at baseline, the end of the 9-week treatment period and the 6-month, and 18-month follow-up via the Insomnia Severity Index (ISI) and sleep diaries. Sleep diaries were administered online and collected for a period of 10 days (within a 2-week window), at each assessment time point. Sleep diaries were used to calculate diary-derived composite variables, including sleep onset latency (SOL, minutes to fall asleep) and wake after sleep onset (WASO, minutes awake during the night).
Data from the Pivotal Trial – UVA also supports to the proposed indications of use. This additional pivotal trial, NCT01438697, is an investigator-initiated study, funded by the National Institute of Mental Health (NIMH) and titled "An Internet Intervention for Insomnia: Efficacy and Dissemination." The randomized controlled trial of 303 adults with chronic insomnia was led by investigators at the University of Virginia (UVA Study).
Study participants (n=303) were between the ages of 21-65, with sleep-onset insomnia and/or sleep maintenance insomnia (>30 minutes for at least 3 nights/week), insomnia symptoms lasting at least 6 months, an average total sleep time 7 points):
- Week 9: 62.8% (UC+SHUTi) vs. 14.0% (UC+Control), p 7 points):
- Week 9: 52.6% (UC+SHUTi) vs. 16.9% (UC+Control), p
§ 882.5801 Computerized behavioral therapy device for psychiatric disorders.
(a)
Identification. A computerized behavioral therapy device for psychiatric disorders is a prescription only device intended to provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment to patients with psychiatric conditions. The digital therapy is intended to provide patients access to therapy tools used during treatment sessions to improve recognized treatment outcomes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a validated model of behavioral therapy for the psychiatric disorder; and
(ii) Validate the model of behavioral therapy as implemented by the device.
(2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) The following labeling must be provided:
(i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device.
(ii) Patient and physician labeling must list compatible devices.
(iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy.
(iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient's medication.
(v) Physician labeling must include a summary of the clinical testing with the device.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
September 15, 2023
Pear Therapeutics, Inc. Yuri Maricich, MD, MBA Chief Medical Officer and Head of Development 201 Mission St. #1450 San Francisco, CA 94105
Re: K191716
Trade/Device Name: Somryst Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized behavioral therapy device for psychiatric disorders Regulatory Class: Class II Product Code: QVO
Dear Dr. Maricich:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 23, 2020. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Pamela Scott, OHT5: Office of Neurological and Physical Medicine Devices, 301-796-5433, PamelaD.Scott@fda.hhs.gov.
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
March 23, 2020
Pear Therapeutics, Inc. Yuri Maricich, MD, MBA Chief Medical Officer and Head of Development 201 Mission St. #1450 San Francisco, California 94105
Re: K191716
Trade/Device Name: Somryst Regulation Number: 21 CFR 882.5801 Regulation Name: Computerized Behavioral Therapy Device For Psychiatric Disorders Regulatory Class: Class II Product Code: PWE Dated: February 26, 2020 Received: February 27, 2020
Dear Dr. Maricich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K191716
Device Name Somryst
Indications for Use (Describe)
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chromic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ⊠ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY K191716
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for Somryst is provided below.
1. SUBMITTER
| Applicant | Pear Therapeutics, Inc.
201 Mission St. #1450
San Francisco, CA 94105
Tel: 617-932-7108
Fax: N/A |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Yuri Maricich, MD, MBA
Chief Medical Officer and Head of Development
Ph: 206-369-9784
E-mail: yuri.maricich@peartherapeutics.com |
| Submission
Contact | Stephen Sherman
Vice President Regulatory Affairs
Ph: 617-456-7682
E-mail: Stephen. Sherman@peartherapeutics.com |
| Date Prepared | 25 February 2020 |
2. DEVICE
| Device Trade
| Name | Somryst™ |
|---|---|
| Device Common | |
| Name | Prescription digital therapeutic for chronic insomnia |
| Classification | |
| Name | 21 CFR 882.5801 Computerized behavioral therapy device for psychiatric disorders |
| Regulatory Class | II |
| Product Code | QVO |
3. PREDICATE DEVICE
| Sponsor | Pear Therapeutics, Inc. |
|---|---|
| Product | reSET® |
| Regulatory Filing | DEN160018 |
5
Pear Therapeutics. Inc. Somryst Traditional 510(k) Premarket Notification Submission
4. DEVICE DESCRIPTION
Somryst is a 9-week prescription digital therapeutic (computerized behavioral therapy) used in the treatment of chronic insomnia. Somryst is based on principles of Cognitive Behavioral Therapy (CBT) for Insomnia, Sleep Restriction, and other proven psychosocial treatment elements, which are delivered in a sequence of "cores" of patient education, training and skill building. The therapy is delivered via a mobile application intended to be used on a patient's mobile device and consists of text, video, animation and graphics. Clinicians, as part of a patient's general treatment program, have access to a clinician dashboard that shows patient utilization and engagement with the application.
INTENDED USE/ INDICATIONS FOR USE ડ.
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-1) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.
6. SUBSTANTIAL EQUIVALENCE
Somryst is a prescription digital therapeutic that is considered a computerized behavioral therapy device for a psychiatric disorder (chronic insomnia) per 21 CFR 882.5801, like reSET®, the proposed predicate from Pear Therapeutics. Somryst shares the same Intended Use, and differs in Indications for Use, as it is used in patients with chronic insomnia instead of Substance Use Disorder (SUD) like the predicate. However, the differences in indications do not represent a new Intended Use, as they are related only to the different psychiatric disorder being treated and the different standard of care in each patient population as compared to the predicate.
Somryst and reSET have similar technological characteristics. They are both comprised of a patient-facing mobile medical application to deliver a form of Cognitive Behavioral Therapy and a clinician dashboard to facilitate patient management, tracking, and clinical decision-making, have substantially similar software architecture and features, utilize the same therapeutic delivery components (text, audio, visuals, video), and are both prescription digital therapeutic devices. Somryst has the same Intended Use as reSET, and minor differences in technological characteristics. The software and clinical validation data demonstrate that Somryst doesn't raise different types of questions of safety or effectiveness. Thus, considering available performance testing, Somryst is considered substantially equivalent to reSET.
6.1. Intended Use Analysis
Both the subject device (Somryst) and the predicate device (reSET) are computerized behavioral therapy devices for psychiatric disorders. The products deliver digitized CBT, are deployed through mobile applications for smart devices, have a sequence of content modules with similar behavioral treatment techniques, software architecture, and are both prescription devices. The indications are for different psychiatric disorders; however, this does not constitute a new intended use and thus, reSET can be used as the predicate for Somryst.
6
Pear Therapeutics, Inc. Somryst Traditional 510(k) Premarket Notification Submission
| Characteristic | reSET (Predicate) | Somryst (Candidate) |
|---|---|---|
| Regulatory Classification | 21 CFR 882.5801 Computerized behavioral | |
| therapy device for psychiatric disorders. | 21 CFR 882.5801 Computerized behavioral | |
| therapy device for psychiatric disorders. | ||
| Indications for Use | Increase abstinence and retention in patients | |
| with Substance Use Disorder (SUD) | Treat patients with chronic insomnia. | |
| Intended User Population | Patients, Licensed healthcare providers | |
| (physicians, practitioners, psychologists, | ||
| and registered nurses) | Patients, Licensed healthcare providers | |
| (physicians, practitioners, psychologists, and | ||
| registered nurses) | ||
| Medical Device Type | Software as a Medical Device (SaMD) | Software as a Medical Device (SaMD) |
| Prescription | Yes | Yes |
| Software Architecture | Patient facing mobile application, clinician | |
| facing dashboard, backend services | Patient facing mobile application, clinician | |
| facing dashboard, backend services | ||
| Mechanism of Action | Cognitive Behavioral Therapy (for SUD) | Cognitive Behavioral Therapy (for Insomnia) |
| Software Content | Text, video and audio content | Text, video and audio content |
| Therapy Duration | 12-weeks (90 days) | 9-weeks (63 days) |
| User Interface | Software application that requires users to | |
| log in, go through modules of therapeutic | ||
| content (text, video, audio), interact with | ||
| device (through quizzes, contingency | ||
| management, reporting cravings, etc.), and | ||
| receive prompts/ feedback. | Software application that requires users to log | |
| in, go through modules of therapeutic content | ||
| (text, video, audio), interact with device | ||
| (through sleep diary and interactive activities, | ||
| etc.), and receive prompts/ feedback. | ||
| Mobile Platform | Smartphones, tablets (iOS and Android) | Smartphones, tablets (iOS and Android) |
6.2. Technological Characteristics Comparison
The minor differences in technological characteristics reflect the different clinical needs for the user populations (chronic insomnia vs. substance use disorder) and the disease-specific CBT for each. These differences do not raise different types of questions of safety and effectiveness.
7. PERFORMANCE DATA
7.1. Non-clinical Testing
Software verification and validation testing was completed and documentation was provided as recommended by Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) for a Moderate Level of Concern device.
7
7.2. Clinical Testing
A responsive browser-based equivalent to Somryst ("SHUTi") was evaluated in "The GoodNight Study: Prevention of Depression Through Internet-based Insomnia Treatment', a large-scale, randomized controlled trial (ACTRN12611000121965) sponsored by the National Health and Medical Research Council (NHMRC).[1], [2], [3] This trial was performed by the Australian National University in collaboration with investigators at the Black Dog Institute, University of Sydney, and University of Virginia. The main objective of the study was to evaluate the efficacy of a web-based insomnia intervention, Sleep Healthy Using the Internet (SHUTi) for treatment of patients with chronic insomnia against a control arm of Usual Care (UC) and an attention-matched control (HealthWatch). [1], [2]
All study participants received usual care (UC) consisting of behavioral treatment, pharmacotherapy and/or self-treatment (e.g. visit to a general practitioner for sleep and/or mood problems, pharmacotherapy (e.g. for sleep and/or mood problems), over-the-counter sleep aids, visit to a sleep specialist, visit to a mental health provider).
Participants were randomized 1:1 to 9 weeks of treatment with the following:
- UC+SHUTi: Usual Care + SHUTi (now known as SomrystTM) ●
- UC+Control: Usual Care + Attention-matched, Digital Control
The Digital Control intervention (HealthWatch) was an interactive health and lifestyle web program that contained information about a range of health content (e.g., environmental health, nutrition, activity, medication) but had no specific mental health or sleep-related content. HealthWatch also administered weekly surveys on these topics to match for interaction required in the treatment group.
Participants in the UC+SHUTi group (n=574) were asked to complete all six Cores within the 9week treatment period. Participants randomized to UC+Control (n=575) were asked to complete nine internet-delivered modules within the 9-week treatment program, thus matching the attention components of SHUTi. Insomnia symptoms were evaluated for all participants at baseline, the end of the 9-week treatment period and the 6-month, and 18-month follow-up via the Insomnia Severity Index (ISI) and sleep diaries. Sleep diaries were administered online and collected for a period of 10 days (within a 2-week window), at each assessment time point. Sleep diaries were used to calculate diary-derived composite variables, including sleep onset latency (SOL, minutes to fall asleep) and wake after sleep onset (WASO, minutes awake during the night).
Insomnia Severity Index (ISI)
Insomnia severity was reduced at both week 9 (p 7 points clinically. A reduction of 7 or more points is considered optimal to detect treatment responders as it represents a threshold change in insomnia severity category.[4] Remitters were defined as participants achieving an ISI score of 7 points on the ISI from baseline), 62.8% of the UC+SHUTi group were deemed treatment responders from baseline to week 9 compared with 14.0% of the UC+Control group. At the 6 months follow-up, 56.2% of the UC+SHUTi group and 18.9% of the UC+Control group were considered responders. At month 12 follow-up, 59.3% of the UC+SHUTi group and 25.2% of the UC+Control were deemed treatment responders. The difference between treatment groups was significant at all timepoints evaluated (p 7 points from baseline) by timepoint.
| Time of Assessment | UC+SHUTi Proportion | UC+Control Proportion | P value |
|---|---|---|---|
| End of Treatment Period | |||
| (Week 9) | 157 (62.8%) | 48 (14.0%) | 30 minutes for at least 3 nights/week), insomnia symptoms lasting at least 6 months, an average total sleep time ≤ 6.5 hours per night, and reported significant distress or impairment in social, occupational, or other areas of functioning caused by sleep disturbances (or associated daytime fatigue). |
All study participants received Usual Care (UC) consisting of behavioral treatment, pharmacotherapy and/or self-treatment (e.g., visit to a general practitioner for sleep and/or mood (e.g. pharmacotherapy (e.g., for sleep and/or mood problems), over-the-counter sleep aids, visit to a sleep specialist, visit to a mental health provider. The Digital Control program provided access to nontailored and fixed digital material about insomnia symptoms; the effect, prevalence, and causes of insomnia; when to see a physician; and basic lifestyle, environmental, and behavioral strategies to improve sleep.
The evaluation of safety and effectiveness of SHUTi to improve sleep, perceived health status, and overall quality of life was evaluated. Participants were randomized 1:1 to 9 weeks of treatment with
10
one of the following:
- UC+SHUTi: Usual Care + SHUTi
- . UC+Control: Usual Care + digital patient education for insomnia
Participants in the UC+ SHUTi group (n=151) were asked to complete all six Cores within the 9-week treatment period. Participants randomized to UC+Control (n=152) were able to read the patient education material immediately upon completion of the baseline assessments and could log in to review the material as often as they desired throughout the treatment period. Insomnia symptoms were evaluated for all participants at baseline, the end of the 9-week treatment period and the 6- and 12month follow-up via the ISI and sleep diaries were administered online and collected for a period of 10 days (within a 2-week window), at each assessment time point. Diaries were used to calculate diary-derived variables, including SOL and WASO.
The primary outcome measures of the study were insomnia symptoms, SOL, and WASO measured via ISI and daily sleep diary data at the end of the 9-week treatment period and the 6- and 12-month follow-up.
Insomnia severity was reduced at both week 9 (p 7 points clinically. A reduction of 7 or more points is considered optimal to detect treatment responders as it represents a threshold change in insommia severity category.[4] Remitters were defined as participants achieving an ISI score of 7 points on the ISI from baseline), 52.6% of the UC+SHUTi arm were deemed treatment responders at week 9 compared with 16.9% of the UC+Control arm. At month 6 follow-up, 59.6% of the UC+SHUTi arm and 35.7% of the UC+Control arm were considered responders. At month 12 follow-up, 69.7% of the UC+SHUTi arm and 43.0% of the UC+Control arm were deemed treatment responders. The difference between treatment groupswas significant at all timepoints evaluated.
11
| Time of Assessment | UC+SHUTi Proportion | UC+Control Proportion | P value |
|---|---|---|---|
| End of Treatment Period | |||
| (Week 9) | 70 (52.6%) | 24 (16.9%) | 7 points from baseline) by timepoint. |
Note: p values are not adjusted for multiplicity and analyses are based on available patient data.
A similar pattern was observed for insommia remittance (Table 5). Using an ISI score of