A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic

Study Overview
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Brief Summary
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The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.

Detailed Description
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This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview.

Official Title
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Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Device: PEAR-003A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide electronic informed consent prior to any study specific assessments being performed Between 22 and 75 years old, inclusively Insomnia as defined by an ISI score of 8 or above Insomnia symptoms for at least 3 months < or = 6.5 hours of sleep per night Access to a mobile device Resident of the United States and currently living in the United States for the duration of the trial. Exclusion Criteria: Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) Unstable medication regimen (change to schedule or dosage within the past 3 months) Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am. Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs. Pregnant or planning to become pregnant during the course of the trial. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias) Participated in an investigational research study in the past 30 days

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAR-003A<br>Digital Therapeutic | Device: PEAR-003A<br>* PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) | Change in the Insomnia Severity Index's (ISI) total score from Baseline to End of Treatment and Follow-up. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant) | From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate PEAR-003A Engagement Data | Evaluate PEAR-003A engagement rates | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 
| Evaluate PEAR-003A Adherence Data | Evaluate PEAR-003A adherence rates | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 
| Examine change in depression symptoms | Change in the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant) | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 
| Examine change in anxiety symptoms | Change in the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant) | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Therapeutic, CBT-I, Chronic Insomnia