MedTrace Logo

Prescription Digital Therapeutic for the Treatment of Insomnia

NCT04909229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-28

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

PEAR-003b PDT Intervention

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

DEVICE

Fitbit

Patients will receive a Fitbit and receive standard of care

BEHAVIORAL

Sleep education materials

Patients will receive sleep hygiene and healthy sleep tips.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • National Evaluation System for health Technology Coordinating Center

    collaborator OTHER

  • Pear Therapeutics, Inc.

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Joseph S Ross, MD MHS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-03-03
Completion
2024-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04909229 on ClinicalTrials.gov