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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 is a NA study that has completed, run by Yale University. The registered enrollment target is 100 participants.

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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

Interventions

  • DEVICE Fitbit
  • DEVICE PEAR-003b PDT Intervention
  • BEHAVIORAL Sleep education materials

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-12-20
Est. Completion 2024-03-01
Phase NA

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT04909229

The ClinicalTrials.gov registry entry for NCT04909229 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Fitbit is the first listed.

NCT04909229 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.