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NCT01804036 · ClinicalTrials.gov registry record · Phase 2
Two Contrasting Interventions for Sleep Management
A Phase 2 study of Primary Insomnia and Secondary Insomnia, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT01804036: Completed Phase 2 study of Primary Insomnia and Secondary Insomnia, sponsored by University of Utah.
NCT01804036 is a Phase 2 study of Primary Insomnia and Secondary Insomnia that has completed, run by University of Utah. The registered enrollment target is 72 participants, below the 120-participant average among 12 other Primary Insomnia trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01804036, a Phase 2 study of Primary Insomnia and Secondary Insomnia, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.
Primary Outcome
Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.
Conditions Studied
Interventions
- DRUG Zolpidem
- BEHAVIORAL Mind-Body Bridging
Study Locations (2)
Colorado
- Evans Army Community Hospital - Colorado Springs
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
What the finished NCT01804036 record still lists
NCT01804036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 120-participant average among 12 other Primary Insomnia trials with a reported enrollment target (40% lower).
The record links to 2 conditions, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Zolpidem is the first listed.
NCT01804036 reports a single indexed study location in Colorado, Utah.
Frequently Asked Questions
What is clinical trial NCT01804036 about?
NCT01804036 is a clinical study titled "Two Contrasting Interventions for Sleep Management". This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc,...
What is the current status of trial NCT01804036?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2013-03. Estimated completion is 2016-11.
What conditions does trial NCT01804036 study?
This clinical trial studies the following conditions: Primary Insomnia, Secondary Insomnia.
What interventions are being tested in trial NCT01804036?
The interventions under investigation include: Zolpidem (DRUG), Mind-Body Bridging (BEHAVIORAL).
Who is sponsoring clinical trial NCT01804036?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01804036 being conducted?
This trial has 2 study locations across Colorado, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary 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 NCT01804036's enrollment target sits among peer trials
72 5th of 12 higher than 8 of 12 other Primary Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary 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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