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NCT05991492 · ClinicalTrials.gov registry record · NA

Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application

A NA study of Insomnia, sponsored by Brigham and Women's Hospital.

Active
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT05991492 is a NA study of Insomnia that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 60 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05991492, a NA study of Insomnia, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and effective self-management tool for treatment of insomnia. This pilot study would test the efficacy of a new digital CBT-I application called Stellar Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the efficacy of this application will provide the preliminary data necessary for larger trials to further validate the application and determine its role for future patients. Use of this application can help bridge the gap in providing care to insomnia patients with transportation and cost barriers and to accommodate the long wait times for traditional in-person CBT-I. It will also be the first web-based CBT-I application that can directly upload data from a wearable device.

Conditions Studied

Interventions

  • DEVICE Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2024-02-13
Est. Completion 2026-07
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT05991492

The ClinicalTrials.gov registry entry for NCT05991492 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I is the first listed.

NCT05991492 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05991492 about?

NCT05991492 is a clinical study titled "Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application". Insomnia is an important public health problem and the most common sleep disorder in the general population. Up to 20% of adults in the United States suffer from insomnia disorder, and it has been associated with increased morbidity, mortality, and healthcare costs. Cognitive behavioral therapy for ...

What is the current status of trial NCT05991492?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2024-02-13. Estimated completion is 2026-07.

What conditions does trial NCT05991492 study?

This clinical trial studies the following conditions: Insomnia.

What interventions are being tested in trial NCT05991492?

The interventions under investigation include: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I (DEVICE).

Who is sponsoring clinical trial NCT05991492?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05991492 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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