Prescription Digital Therapeutic for the Treatment of Insomnia

NCT04909229 | Completed Results FDA Device

• 1 other identifier: 2000029050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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 for 61 weeks

Conditions

Insomnia Chronic

Keywords

insomnia; CBT-I

Outcome Measures

Primary Outcomes (1)

• 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)

  From baseline to 9 weeks post randomization

Secondary Outcomes (47)

• Change in Insomnia Severity

  From baseline to 21 weeks post-randomization

• Change in Insomnia Severity

  From baseline to 35 weeks post-randomization

• Change in Insomnia Severity

  From baseline to 61 weeks post-randomization

• Change in Depressive Symptoms

  From baseline to 9 weeks post-randomization

• Change in Depressive Symptoms

  From baseline to 21 weeks post-randomization

Study Arms (2)

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.

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.

Device: Fitbit; Behavioral: Sleep education materials

Interventions

PEAR-003b PDT Intervention DEVICE

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

PEAR-003b PDT Intervention

Fitbit DEVICE

Patients will receive a Fitbit and receive standard of care

Control Arm; PEAR-003b PDT Intervention

Sleep education materials BEHAVIORAL

Patients will receive sleep hygiene and healthy sleep tips.

Control Arm; PEAR-003b PDT Intervention

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• Mayo Clinic: collaborator
• National Evaluation System for health Technology Coordinating Center: collaborator
• Pear Therapeutics, Inc.: collaborator

Study Sites (2)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 35940841 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Joseph Ross, MD, MHS
• Organization: Yale University

joseph.ross@yale.edu

203-785-2987

Study Officials

• Joseph S Ross, MD MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 1, 2021
• Study Start: December 20, 2021
• Primary Completion: March 3, 2023
• Study Completion: March 1, 2024
• Last Updated: July 28, 2025
• Results First Posted: March 29, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available once the study has been completed

Locations

US (2)