CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
PEAR-003b PDT Intervention +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04909229
NCT04909229N/ACompleted
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Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia

Yale University·interventional·Posted Jun 1, 2021·Updated Jul 28, 2025

In Brief

A clinical study evaluating PEAR-003b PDT Intervention, Fitbit, and 1 other intervention for Insomnia Chronic. Completed, enrolled 100 participants across 2 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Chronic
CountriesUnited States
CollaboratorsMayo Clinic, National Evaluation System for health Technology Coordinating Center, Pear Therapeutics, Inc.

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 1, 2021
Enrollment StartDec 20, 2021
Primary CompletionMar 3, 2023
Study CompletionMar 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.1 years ago

Interventions

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 materialsbehavioral

Patients will receive sleep hygiene and healthy sleep tips.