Insomnia ChronicSLEEP-INCT04909229
Prescription Digital Therapeutic for the Treatment of Insomnia
A study testing PEAR-003b PDT Intervention, Fitbit and Sleep education materials in people with Insomnia Chronic, run by Yale University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 to 64 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- PEAR-003b PDT Intervention, Fitbit and Sleep education materials
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2021to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Randomized Controlled Trial Examining Real-World Effectiveness of a 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
Read the detailed description
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.
- Conditions
- Insomnia Chronic
- Being tested
- PEAR-003b PDT Intervention, Fitbit, Sleep education materials
- Keywords
- insomnia, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAR-003b PDT InterventionDevice
The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
FitbitDevice
Patients will receive a Fitbit and receive standard of care
Sleep education materialsBehavioural
Patients will receive sleep hygiene and healthy sleep tips.
| Study group | Role | What they receive |
|---|---|---|
| PEAR-003b PDT Intervention | Experimental | Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Receives: Device: PEAR-003b PDT Intervention; Device: Fitbit; Behavioral: Sleep education materials |
| Control Arm | Placebo comparator | Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. Receives: Device: Fitbit; Behavioral: Sleep education materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity
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)
Measured: From baseline to 9 weeks post randomization
Secondary outcomes (47)
Change in Insomnia Severity
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)
Measured: From baseline to 21 weeks post-randomization
Change in Insomnia Severity
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)
Measured: From baseline to 35 weeks post-randomization
Change in Insomnia Severity
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)
Measured: From baseline to 61 weeks post-randomization
Change in Depressive Symptoms
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)
Measured: From baseline to 9 weeks post-randomization
Change in Depressive Symptoms
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)
Measured: From baseline to 21 weeks post-randomization
Change in Depressive Symptoms
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)
Measured: From baseline to 35 weeks post-randomization
Change in Depressive Symptoms
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)
Measured: From baseline to 61 weeks post-randomization
Change in Anxiety
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.
Measured: From baseline to 9 weeks post-randomization
Change in Anxiety
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.
Measured: From baseline to 21 weeks post-randomization
Change in Anxiety
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.
Measured: From baseline to 35 weeks post-randomization
Change in Anxiety
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.
Measured: From baseline to 61 weeks post-randomization
Change in Stress
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.
Measured: From baseline to 9 weeks post-randomization
Change in Stress
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.
Measured: From baseline to 21 weeks post-randomization
Change in Stress
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.
Measured: From baseline to 35 weeks post-randomization
Change in Stress
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.
Measured: From baseline to 61 weeks post-randomization
Change in Quality of Life (PCS)
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.
Measured: From baseline to 9 weeks post-randomization
Change in Quality of Life (PCS)
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.
Measured: From baseline to 21 weeks post-randomization
Change in Quality of Life (PCS)
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.
Measured: From baseline to 35 weeks post-randomization
Change in Quality of Life (PCS)
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.
Measured: From baseline to 61 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Measured: From baseline to 9 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Measured: From baseline to 21 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Measured: From baseline to 35 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Measured: From baseline to 61 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Measured: From baseline to 9 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Measured: From baseline to 21 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Measured: From baseline to 35 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Measured: From baseline to 61 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Measured: From baseline to 9 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Measured: From baseline to 21 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Measured: From baseline to 35 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Measured: From baseline to 61 weeks post-randomization
Change in Sleep Efficiency
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)
Measured: From baseline to 9 weeks post-randomization
Change in Sleep Efficiency
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)
Measured: From baseline to 21 weeks post-randomization
Change in Sleep Efficiency
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)
Measured: From baseline to 35 weeks post-randomization
Change in Sleep Efficiency
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)
Measured: From baseline to 61 weeks post-randomization
Change in Sleep Onset Latency
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.
Measured: From baseline to 9 weeks post-randomization
Change in Sleep Onset Latency
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.
Measured: From baseline to 21 weeks post-randomization
Change in Sleep Onset Latency
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.
Measured: From baseline to 35 weeks post-randomization
Change in Sleep Onset Latency
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.
Measured: From baseline to 61 weeks post-randomization
Change in Health Utility Score
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.
Measured: From baseline to 9 weeks post-randomization
Change in Health Utility Score
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.
Measured: From baseline to 21 weeks post-randomization
Change in Health Utility Score
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.
Measured: From baseline to 35 weeks post-randomization
Change in Health Utility Score
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.
Measured: From baseline to 61 weeks post-randomization
Change in Quality of Life (MCS)
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.
Measured: From baseline to 9 weeks post-randomization
Change in Quality of Life (MCS)
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.
Measured: From baseline to 21 weeks post-randomization
Change in Quality of Life (MCS)
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.
Measured: From baseline to 35 weeks post-randomization
Change in Quality of Life (MCS)
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.
Measured: From baseline to 61 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start20 Dec 2021
- Primary completion3 Mar 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, National Evaluation System for health Technology Coordinating Center, Pear Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph S Ross, MD MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909229
- Sponsor's protocol ID
- 2000029050
- Acronym
- SLEEP-I
- Status last verified
- Jul 2025
- First submitted
- 23 May 2021
- Last updated
- 28 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes. The exact plan has yet to be decided.
Publications
Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Aug 8;12(8):e062041. doi: 10.1136/bmjopen-2022-062041.
PubMed 35940841
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT04909229
- Acronym / sponsor ID
- SLEEP-I / 2000029050
- Conditions
- Insomnia Chronic
- Keywords
- insomnia, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Evaluation System for health Technology Coordinating Center, Pear Therapeutics, Inc.
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEAR-003b PDT Intervention | Experimental | Device: PEAR-003b PDT Intervention, Device: Fitbit, Behavioral: Sleep education materialsParticipants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. |
| Control Arm | Placebo comparator | Device: Fitbit, Behavioral: Sleep education materialsParticipants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected. |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Age between 22-64 years
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAR-003b PDT InterventionThe PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks. | Device | PEAR-003b PDT Intervention |
| FitbitPatients will receive a Fitbit and receive standard of care | Device | Control Arm, PEAR-003b PDT Intervention |
| Sleep education materialsPatients will receive sleep hygiene and healthy sleep tips. | Behavioural | Control Arm, PEAR-003b PDT Intervention |
Primary outcome
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)
47 secondary outcomes
Change in Insomnia Severity
Time frame: From baseline to 21 weeks post-randomization
Change in Insomnia Severity
Time frame: From baseline to 35 weeks post-randomization
Change in Insomnia Severity
Time frame: From baseline to 61 weeks post-randomization
Change in Depressive Symptoms
Time frame: From baseline to 9 weeks post-randomization
Change in Depressive Symptoms
Time frame: From baseline to 21 weeks post-randomization
Change in Depressive Symptoms
Time frame: From baseline to 35 weeks post-randomization
Change in Depressive Symptoms
Time frame: From baseline to 61 weeks post-randomization
Change in Anxiety
Time frame: From baseline to 9 weeks post-randomization
Change in Anxiety
Time frame: From baseline to 21 weeks post-randomization
Change in Anxiety
Time frame: From baseline to 35 weeks post-randomization
Change in Anxiety
Time frame: From baseline to 61 weeks post-randomization
Change in Stress
Time frame: From baseline to 9 weeks post-randomization
Change in Stress
Time frame: From baseline to 21 weeks post-randomization
Change in Stress
Time frame: From baseline to 35 weeks post-randomization
Change in Stress
Time frame: From baseline to 61 weeks post-randomization
Change in Quality of Life (PCS)
Time frame: From baseline to 9 weeks post-randomization
Change in Quality of Life (PCS)
Time frame: From baseline to 21 weeks post-randomization
Change in Quality of Life (PCS)
Time frame: From baseline to 35 weeks post-randomization
Change in Quality of Life (PCS)
Time frame: From baseline to 61 weeks post-randomization
Change in Daytime Sleepiness
Time frame: From baseline to 9 weeks post-randomization
Change in Daytime Sleepiness
Time frame: From baseline to 21 weeks post-randomization
Change in Daytime Sleepiness
Time frame: From baseline to 35 weeks post-randomization
Change in Daytime Sleepiness
Time frame: From baseline to 61 weeks post-randomization
Healthcare Utilization
Time frame: From baseline to 9 weeks post-randomization
Healthcare Utilization
Time frame: From baseline to 21 weeks post-randomization
Healthcare Utilization
Time frame: From baseline to 35 weeks post-randomization
Healthcare Utilization
Time frame: From baseline to 61 weeks post-randomization
Medication Utilization
Time frame: From baseline to 9 weeks post-randomization
Medication Utilization
Time frame: From baseline to 21 weeks post-randomization
Medication Utilization
Time frame: From baseline to 35 weeks post-randomization
Medication Utilization
Time frame: From baseline to 61 weeks post-randomization
Change in Sleep Efficiency
Time frame: From baseline to 9 weeks post-randomization
Change in Sleep Efficiency
Time frame: From baseline to 21 weeks post-randomization
Change in Sleep Efficiency
Time frame: From baseline to 35 weeks post-randomization
Change in Sleep Efficiency
Time frame: From baseline to 61 weeks post-randomization
Change in Sleep Onset Latency
Time frame: From baseline to 9 weeks post-randomization
Change in Sleep Onset Latency
Time frame: From baseline to 21 weeks post-randomization
Change in Sleep Onset Latency
Time frame: From baseline to 35 weeks post-randomization
Change in Sleep Onset Latency
Time frame: From baseline to 61 weeks post-randomization
Change in Health Utility Score
Time frame: From baseline to 9 weeks post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35940841Dreyer RP, Berkowitz A, Yaggi HK, Schneeberg L, Shah ND, Emanuel L, Kolla B, Jeffery MM, Deeg M, Ervin K, Thorndike F, Ross JS. PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. BMJ Open. 2022 Aug 8;12(8):e062041. doi: 10.1136/bmjopen-2022-062041.
- Individual participant dataSharing planned: Yes. Once the study has been completed, IPD will be shared in a way which will protect patient confidentiality using a data sharing platform for research purposes. The exact plan has yet to be decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph S Ross, MD MHS principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAR-003b PDT Intervention, Fitbit and Sleep education materials in people with Insomnia Chronic, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity (time frame: From baseline to 9 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.