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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: Active NA study of Insomnia, sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-02-13 |
| Est. Completion | 2026-07 |
| Phase | NA |
What the registry record for NCT05991492 still lists
NCT05991492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05991492's enrollment target sits among peer trials
60 89th of 151 higher than 58 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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
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