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NCT00256503 · ClinicalTrials.gov registry record · NA
Sleep Homeostasis in Primary Insomnia
A NA study of Primary Insomnia, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00256503 is a NA study of Primary Insomnia that has completed, run by University of Rochester. The registered enrollment target is 18 participants, below the 125-participant average among 12 other Primary Insomnia trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00256503, a NA study of Primary Insomnia, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
About 10% of the population is believed to suffer from Primary Insomnia. It is also believed that people with chronic insomnia have a sleep system that is essentially out of alignment (we call this "homeostatic dysregulation"). We also know that a certain form of non-medication therapy called cognitive-behavioral therapy is a very effective treatment for insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by bringing the brain's sleep system back into alignment ("sleep homeostasis"). One of the methods used to measure sleep homeostasis is to observe a person's brain waves during sleep and particularly during sleep that follows a period of sleep loss. The purposes of this study are to first learn whether persons with insomnia do have a misaligned sleep system compared to persons who do not have insomnia by assessing the sleep of people before and after a period of extended sleep loss. Second, the study will determine whether cognitive-behavioral therapy can re-regulate the sleep system and its response to sleep loss. Third, the final purpose is to examine whether the immune system of people with insomnia is more altered following sleep loss than in the comparison group and whether cognitive-behavioral therapy can alter immune function.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive-Behavioral Therapy for Insomnia
Study Locations (1)
New York
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2005-12 |
| Est. Completion | 2008-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00256503
The ClinicalTrials.gov registry entry for NCT00256503 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 12 other Primary Insomnia trials with a reported enrollment target (86% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 1 intervention - of which Cognitive-Behavioral Therapy for Insomnia is the first listed.
NCT00256503 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00256503 about?
NCT00256503 is a clinical study titled "Sleep Homeostasis in Primary Insomnia". About 10% of the population is believed to suffer from Primary Insomnia. It is also believed that people with chronic insomnia have a sleep system that is essentially out of alignment (we call this "homeostatic dysregulation"). We also know that a certain form of non-medication therapy called cognit...
What is the current status of trial NCT00256503?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2005-12. Estimated completion is 2008-12.
What conditions does trial NCT00256503 study?
This clinical trial studies the following conditions: Primary Insomnia.
What interventions are being tested in trial NCT00256503?
The interventions under investigation include: Cognitive-Behavioral Therapy for Insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT00256503?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00256503 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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