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Completed

NCT Number: NCT04909229

Prescription Digital Therapeutic for the Treatment of Insomnia

This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks

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Key information

Conditions

Insomnia Chronic Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

22 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital, New Haven, Connecticut, United States

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About this study

This is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia (i.e., Somryst, herein called PEAR-003b) using a novel patient-centered data sharing platform (called Hugo), with linkage to Fitbit (Inspire 2), among 100 patients with chronic insomnia. Half of the patients with insomnia will receive the PEAR-003b digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the PDT but will receive a Fitbit and be enrolled in the Hugo platform. The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up. All patients will be evaluated at baseline, as well as prompted to complete additional assessments at weeks 9, 21, 35, and 61. The PEAR-003b intervention will deliver CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Additionally, the Hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes. These real-world data points and trends collected as part of this pilot investigation will help inform a future larger healthcare effectiveness and outcomes research study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Age between 22-64 years
  • English-speaking (both reading and writing in English required)
  • Diagnosis of chronic insomnia
  • Participant is willing and able to give consent and participate in study
  • Participant has an email account or is willing to create one and a smartphone able to download the necessary applications
  • Participant is willing and able to use the PDT, the Hugo data sharing platform and the syncable devices (e.g. Fitbit)
  • Participant has primary care at YNHH or Mayo Clinic

Exclusion criteria

  • Pregnancy
  • Shift work or family/other commitments that interfere with establishment of regular night-time sleep patterns, and if wake/sleep time is outside the ranges of 4:00h - 10:00h (wake time) and 20:00h - 02:00h (bed time)
  • Absence of a reliable internet access and smartphone
  • A reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction
  • Current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications)
  • Those with untreated co-existing sleep conditions (e.g. sleep apnea)
  • Those who have failed CBT for insomnia in the past

Treatment and study plan

PEAR-003b PDT Intervention

Device

The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.

Fitbit

Device

Patients will receive a Fitbit and receive standard of care

Sleep education materials

Behavioral

Patients will receive sleep hygiene and healthy sleep tips.

Primary outcomes

  1. Change in Insomnia Severity

    Time frame: From baseline to 9 weeks post randomization

    Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

Secondary outcomes

  1. Change in Insomnia Severity

    Time frame: From baseline to 21 weeks post-randomization

    Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

  2. Change in Insomnia Severity

    Time frame: From baseline to 35 weeks post-randomization

    Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

  3. Change in Insomnia Severity

    Time frame: From baseline to 61 weeks post-randomization

    Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

  4. Change in Depressive Symptoms

    Time frame: From baseline to 9 weeks post-randomization

    Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  5. Change in Depressive Symptoms

    Time frame: From baseline to 21 weeks post-randomization

    Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  6. Change in Depressive Symptoms

    Time frame: From baseline to 35 weeks post-randomization

    Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  7. Change in Depressive Symptoms

    Time frame: From baseline to 61 weeks post-randomization

    Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  8. Change in Anxiety

    Time frame: From baseline to 9 weeks post-randomization

    The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

  9. Change in Anxiety

    Time frame: From baseline to 21 weeks post-randomization

    The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

  10. Change in Anxiety

    Time frame: From baseline to 35 weeks post-randomization

    The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

  11. Change in Anxiety

    Time frame: From baseline to 61 weeks post-randomization

    The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.

  12. Change in Stress

    Time frame: From baseline to 9 weeks post-randomization

    The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.

  13. Change in Stress

    Time frame: From baseline to 21 weeks post-randomization

    The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.

  14. Change in Stress

    Time frame: From baseline to 35 weeks post-randomization

    The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.

  15. Change in Stress

    Time frame: From baseline to 61 weeks post-randomization

    The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.

  16. Change in Quality of Life (PCS)

    Time frame: From baseline to 9 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.

  17. Change in Quality of Life (PCS)

    Time frame: From baseline to 21 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.

  18. Change in Quality of Life (PCS)

    Time frame: From baseline to 35 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.

  19. Change in Quality of Life (PCS)

    Time frame: From baseline to 61 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.

  20. Change in Daytime Sleepiness

    Time frame: From baseline to 9 weeks post-randomization

    Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  21. Change in Daytime Sleepiness

    Time frame: From baseline to 21 weeks post-randomization

    Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  22. Change in Daytime Sleepiness

    Time frame: From baseline to 35 weeks post-randomization

    Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  23. Change in Daytime Sleepiness

    Time frame: From baseline to 61 weeks post-randomization

    Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)

  24. Healthcare Utilization

    Time frame: From baseline to 9 weeks post-randomization

    Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.

  25. Healthcare Utilization

    Time frame: From baseline to 21 weeks post-randomization

    Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.

  26. Healthcare Utilization

    Time frame: From baseline to 35 weeks post-randomization

    Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.

  27. Healthcare Utilization

    Time frame: From baseline to 61 weeks post-randomization

    Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.

  28. Medication Utilization

    Time frame: From baseline to 9 weeks post-randomization

    Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.

  29. Medication Utilization

    Time frame: From baseline to 21 weeks post-randomization

    Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.

  30. Medication Utilization

    Time frame: From baseline to 35 weeks post-randomization

    Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.

  31. Medication Utilization

    Time frame: From baseline to 61 weeks post-randomization

    Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.

  32. Change in Sleep Efficiency

    Time frame: From baseline to 9 weeks post-randomization

    Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)

  33. Change in Sleep Efficiency

    Time frame: From baseline to 21 weeks post-randomization

    Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)

  34. Change in Sleep Efficiency

    Time frame: From baseline to 35 weeks post-randomization

    Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)

  35. Change in Sleep Efficiency

    Time frame: From baseline to 61 weeks post-randomization

    Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)

  36. Change in Sleep Onset Latency

    Time frame: From baseline to 9 weeks post-randomization

    Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.

  37. Change in Sleep Onset Latency

    Time frame: From baseline to 21 weeks post-randomization

    Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.

  38. Change in Sleep Onset Latency

    Time frame: From baseline to 35 weeks post-randomization

    Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.

  39. Change in Sleep Onset Latency

    Time frame: From baseline to 61 weeks post-randomization

    Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.

  40. Change in Health Utility Score

    Time frame: From baseline to 9 weeks post-randomization

    The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 9 weeks post-randomization.

  41. Change in Health Utility Score

    Time frame: From baseline to 21 weeks post-randomization

    The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 21 weeks post-randomization.

  42. Change in Health Utility Score

    Time frame: From baseline to 35 weeks post-randomization

    The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 35 weeks post-randomization.

  43. Change in Health Utility Score

    Time frame: From baseline to 61 weeks post-randomization

    The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 61 weeks post-randomization.

  44. Change in Quality of Life (MCS)

    Time frame: From baseline to 9 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.

  45. Change in Quality of Life (MCS)

    Time frame: From baseline to 21 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.

  46. Change in Quality of Life (MCS)

    Time frame: From baseline to 35 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.

  47. Change in Quality of Life (MCS)

    Time frame: From baseline to 61 weeks post-randomization

    Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Mayo Clinic
  • National Evaluation System for health Technology Coordinating Center
  • Pear Therapeutics, Inc.

Registry information

Official study title

Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia

Acronym: SLEEP-I

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 1, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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