Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00321451 · ClinicalTrials.gov registry record · Phase 2
Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia
A Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
- 1
- Study location
NCT00321451 is a Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders that has completed, run by Duke University. The registered enrollment target is 111 participants, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00321451, a Phase 2 study of Fibromyalgia and Sleep Initiation and Maintenance Disorders, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
- 1
- Study location
Study Summary
Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may worsen FM-related pain, fatigue, low mood, and low energy. The purpose of this study is to evaluate the effectiveness of cognitive behavioral insomnia therapy in reducing sleep disturbances and improving other FM-related symptoms.
Conditions Studied
Interventions
- OTHER Usual care
- BEHAVIORAL Cognitive behavioral therapy for insomnia
- BEHAVIORAL Pseudo-desensitization procedure
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2006-05 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00321451
The ClinicalTrials.gov registry entry for NCT00321451 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 76 other Fibromyalgia trials with a reported enrollment target (38% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Fibromyalgia appearing as the primary indexed condition, and to 3 interventions - of which Usual care is the first listed.
NCT00321451 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00321451 about?
NCT00321451 is a clinical study titled "Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia". Fibromyalgia (FM) is a common and chronic disorder characterized by widespread muscle pain, fatigue, and multiple tender points. The majority of individuals with FM report sleep problems, including delayed sleep onset, extended awakenings, and non-restorative sleep. These sleep disturbances may wors...
What is the current status of trial NCT00321451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2006-05. Estimated completion is 2011-02.
What conditions does trial NCT00321451 study?
This clinical trial studies the following conditions: Fibromyalgia, Sleep Initiation and Maintenance Disorders.
What interventions are being tested in trial NCT00321451?
The interventions under investigation include: Usual care (OTHER), Cognitive behavioral therapy for insomnia (BEHAVIORAL), Pseudo-desensitization procedure (BEHAVIORAL).
Who is sponsoring clinical trial NCT00321451?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00321451 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fibromyalgia
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.
-
Nitrous Oxide as Treatment for Fibromyalgia
RECRUITING · Phase 2
-
Dextromethorphan in Fibromyalgia
COMPLETED · Phase 2
-
Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
COMPLETED · Phase 2
-
Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
COMPLETED · Phase 2
-
Heart Rate Variability in Response to Metformin Challenge
COMPLETED · Phase 2
-
Gabapentin in Fibromyalgia Trial (GIFT)
COMPLETED · Phase 2
Explore more on PlainTrial
Fibromyalgia
All registered trials for this condition
Sleep Initiation and Maintenance Disorders
All registered trials for this condition
North Carolina
All trials with a study site in North Carolina
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
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.