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NCT02741336 · ClinicalTrials.gov registry record · NA
Electrophysiologic Changes in Blacks Treated With CBT for Insomnia
A NA study, sponsored by State University of New York - Downstate Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT02741336 is a NA study that has completed, run by State University of New York - Downstate Medical Center. The registered enrollment target is 10 participants.
The verdict
NCT02741336, a NA study, has completed, sponsored by State University of New York - Downstate Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Insomnia is a highly prevalent, often debilitating, and economically burdensome condition. Reviews of the literature indicate that there are ethnic differences in sleep behavior, with African Americans objectively and subjectively reporting more disordered sleep than Caucasian Americans.Chronic insomnia can have a significant impact on mental and physical health outcomes and has been associated with impaired cognitive performance, particularly, in areas of speed, attention, working memory, and executive function. In order to understand the brain mechanisms in sleep disorder both during resting state as well as during cognitive processing, the investigators will assess resting state EEG (during eyes-closed and eyes-open conditions) as well as ERP tasks for assessing decision-making and reward processing. The primary objective of the study is to evaluate the effect of a tailored, telephone-delivered cognitive behavioral intervention, versus a self- monitoring control condition, on symptoms of insomnia and its neurodynamic correlates. Hypotheses: Among Blacks subjectively reporting symptoms of insomnia, those randomized to the tailored, telephone-delivered CBT-I, compared with those randomized to the self-monitoring control group, will have: Hyp. 1: Greater reduction in symptoms of insomnia as measured by the Pittsburgh Sleep Quality Index. Hyp. 2: Greater neurophysiologic improvement (ERP, ERO) in the intervention condition in response to laboratory paradigms Hyp 3: Greater improvement in psychosocial functioning including reduction in depression and increase in quality of life.
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
- BEHAVIORAL Self-Monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02741336
The ClinicalTrials.gov registry entry for NCT02741336 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York - Downstate Medical Center, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first listed.
NCT02741336 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02741336 about?
NCT02741336 is a clinical study titled "Electrophysiologic Changes in Blacks Treated With CBT for Insomnia". Insomnia is a highly prevalent, often debilitating, and economically burdensome condition. Reviews of the literature indicate that there are ethnic differences in sleep behavior, with African Americans objectively and subjectively reporting more disordered sleep than Caucasian Americans.Chronic inso...
What is the current status of trial NCT02741336?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2015-11. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02741336?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Self-Monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT02741336?
This trial is sponsored by State University of New York - Downstate Medical Center, which has 18 total clinical trials registered on ClinicalTrials.gov.
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