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NCT03904472 · ClinicalTrials.gov registry record · NA
Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT03904472: Completed NA study, sponsored by University of Michigan.
NCT03904472 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904472, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal of the treatment is to improve the participants insomnia and reflux symptoms. In addition to the cognitive behavioral therapy, participants will be asked to keep a daily diary and periodically complete questionnaires to assess their symptoms.
Primary Outcome
RESQ-7 contains 13 items which are aggregated to 4 frequency and 4 intensity domain scores: heartburn (5 items), regurgitation (4 items), cough, hoarseness, difficulty swallowing (3 items), burping (1 item). Frequency questions are scored from 0-7 and intensity questions are scored from 0-5. The range of scores are 0-156 (0 meaning no symptoms, 156 being the worst).
Interventions
- BEHAVIORAL Web-based CBTI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-04-15 |
| Est. Completion | 2022-03-25 |
| Phase | NA |
What the finished NCT03904472 record still lists
NCT03904472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Web-based CBTI is the first listed.
NCT03904472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03904472 about?
NCT03904472 is a clinical study titled "Cognitive Behavioral Therapy for Insomnia (CBTI) in GERD Patients With Insomnia". This study will enroll patients with persistent reflux symptoms despite proton-pump inhibitor therapy and chronic insomnia. Participants that are eligible for the study and agree to participate will receive cognitive behavioral therapy for insomnia (CBTI) delivered by a web-based approach. The goal ...
What is the current status of trial NCT03904472?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2019-04-15. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT03904472?
The interventions under investigation include: Web-based CBTI (BEHAVIORAL).
Who is sponsoring clinical trial NCT03904472?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03904472's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 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
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