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NCT01487252 · ClinicalTrials.gov registry record · NA
Circadian Phase Assessments at Home
A NA study of Healthy (Controls) and Delayed Sleep Phase, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 1
- Study location
NCT01487252 is a NA study of Healthy (Controls) and Delayed Sleep Phase that has completed, run by Rush University Medical Center. The registered enrollment target is 73 participants, below the 117-participant average among 16 other Healthy (Controls) trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01487252, a NA study of Healthy (Controls) and Delayed Sleep Phase, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 1
- Study location
Study Summary
An estimated 23 million Americans, including adolescents and the elderly, suffer from circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase disorder and winter depression. These conditions are characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, reduced well being and lower quality of life. The negative symptoms result from a misalignment between the timing of sleep and the internal circadian clock. Clinical research has demonstrated that circadian rhythm sleep disorders are most effectively diagnosed (differentiated from other causes of insomnia) and treated if each individual patient's circadian phase is known. The timing of the master internal circadian clock is most reliably measured from the onset of the endogenous circadian rhythm of melatonin, a neuroendocrine hormone, as measured in dim light (dim light melatonin onset, or "DLMO"). However to date the reliable and valid assessment of the DLMO is limited to the research laboratory setting. This study is to test a streamlined procedure for the accurate assessment of circadian phase (DLMO) outside of the laboratory that will provide clinicians and researchers with a novel diagnostic and research tool. In this way the underlying neurobiological cause of a patient's insomnia and/or circadian rhythm disorder can more readily be diagnosed and treated. Specific Aim 1 is to validate procedures for at-home circadian phase assessment in a sample of healthy people. Validation will occur by (1) objectively measuring compliance to the at-home procedures and (2) comparing DLMOs collected at home to DLMOs collected in the laboratory, in a within-subjects counterbalanced design. Specific Aim 2 is to validate the same at home procedures in patients with delayed sleep phase disorder. Specific Aim 3 is to conduct rigorous analyses to inform future users which subject characteristics and light levels predict (1) compliance to the at home procedur
Conditions Studied
Interventions
- BEHAVIORAL At home saliva sampling
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01487252
The ClinicalTrials.gov registry entry for NCT01487252 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 16 other Healthy (Controls) trials with a reported enrollment target (38% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy (Controls) appearing as the primary indexed condition, and to 1 intervention - of which At home saliva sampling is the first listed.
NCT01487252 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT01487252 about?
NCT01487252 is a clinical study titled "Circadian Phase Assessments at Home". An estimated 23 million Americans, including adolescents and the elderly, suffer from circadian rhythm sleep disorders, such as delayed sleep phase disorder, advanced sleep phase disorder and winter depression. These conditions are characterized by persistent insomnia and/or excessive daytime sleepi...
What is the current status of trial NCT01487252?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2011-12. Estimated completion is 2015-05.
What conditions does trial NCT01487252 study?
This clinical trial studies the following conditions: Healthy (Controls), Delayed Sleep Phase.
What interventions are being tested in trial NCT01487252?
The interventions under investigation include: At home saliva sampling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01487252?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01487252 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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