Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04909229 · ClinicalTrials.gov registry record · NA
Prescription Digital Therapeutic for the Treatment of Insomnia
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04909229: Completed NA study, sponsored by Yale University.
NCT04909229 is a NA study that has completed, run by Yale University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04909229, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- DEVICE Fitbit
- DEVICE PEAR-003b PDT Intervention
- BEHAVIORAL Sleep education materials
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-12-20 |
| Est. Completion | 2024-03-01 |
| Phase | NA |
What the finished NCT04909229 record still lists
NCT04909229 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Fitbit is the first listed.
NCT04909229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04909229 about?
NCT04909229 is a clinical study titled "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 wit...
What is the current status of trial NCT04909229?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2021-12-20. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT04909229?
The interventions under investigation include: Fitbit (DEVICE), PEAR-003b PDT Intervention (DEVICE), Sleep education materials (BEHAVIORAL).
Who is sponsoring clinical trial NCT04909229?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04909229's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI