Chronic Insomnia
Conditions
Keywords
Digital Therapeutic, CBT-I, Chronic Insomnia
Brief summary
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
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.
Interventions
DEVICEPEAR-003A
PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
Sponsors
Pear Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provide electronic informed consent prior to any study specific assessments being performed 2. Between 22 and 75 years old, inclusively 3. Insomnia as defined by an ISI score of 8 or above 4. Insomnia symptoms for at least 3 months 5. \< or = 6.5 hours of sleep per night 6. Access to a mobile device 7. Resident of the United States and currently living in the United States for the duration of the trial.
Exclusion criteria
1. 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) 2. Unstable medication regimen (change to schedule or dosage within the past 3 months) 3. Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction 4. 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. 5. 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. 6. Pregnant or planning to become pregnant during the course of the trial. 7. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias) 8. Participated in an investigational research study in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index (ISI) | From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate PEAR-003A Engagement Data | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Evaluate PEAR-003A engagement rates |
| Evaluate PEAR-003A Adherence Data | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Evaluate PEAR-003A adherence rates |
| Examine change in depression symptoms | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 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) |
| Examine change in anxiety symptoms | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To determine if there is a change in daytime sleepiness | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Change in Epworth Sleepiness Scale from baseline to end of treatment and follow-up. The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) |
| To determine change in quality of life | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health |
| Examine treatment responders' data | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Treatment responders are those whose ISI decreased by more than 7 points. Responders ISI score will be evaluated at the end of treatment and follow-up. |
| To evaluate potential changes in healthcare utilization and costs identified in claims | Matched period | Change in tokenized health claims from a specified period (up to 24 months) prior to intervention and a similar period after intervention |
| To determine change in work attendance and productivity | Baseline, Day 63, Day 243, Day 428, Day 610, Day 793 | Change in presenteeism/absenteeism work questions based on a survey. Subject answers Yes/No questions of whether continuously employed during the time period. If not, they can enter number of days employed or missed. Survey also contains a question regarding rating of productivity in %. |
| Examine Insomnia Remission | Day 63, Day 243, Day 428, Day 610, Day 793 | Subjects in treatment remission are those whose ISI score is 8 or less. Subjects in treatment remission ISI scores will be evaluated at end of treatment and follow-up |
| Describe user experience surveys | Baseline, Day 63 | Summarize user experience surveys through descriptive statistics |
| Describe user experience diary data | Baseline, Day 63 | Summarize qualitative diary data through descriptive statistics |
| Describe user experience interviews | Baseline, Day 63 | Summarize user experience interviews through descriptive statistics |
Countries
United States
Outcome results
None listed