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NCT01008176 · ClinicalTrials.gov registry record · NA
Restoring Sleep Homeostasis to Lower Blood Pressure
A NA study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT01008176 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 23 participants.
The verdict
NCT01008176, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
Cutting back on sleep duration has developed into a common, highly prevalent habit in the adult population, and may lead to a major health problem. Large epidemiological studies have demonstrated that short sleep duration is associated with increased risk of cardiovascular disease (CVD). The investigators' preliminary data on the effects of experimental sleep reduction have shown elevation of blood pressure (BP) and inflammatory markers, such as interleukin-6 (IL-6) and C reactive protein (CRP), suggesting that both may play an important role in linking sleep loss and CVD risk. With this background, the investigators hypothesize that restoring sleep homeostasis, i. e. getting adequate amounts of sleep, is an effective behavioral intervention in the treatment of elevated BP. The investigators will test this hypothesis in subjects with BP above normal and with short habitual sleep duration, as verified by sleep logs and actigraphic recordings. Subjects will either undergo 6 weeks of mild sleep extension, in which 60 min of bedtime will be added to the habitual sleep duration, or subjects will maintain their habitual sleep duration for the following 6 weeks. Regarding their first specific aim, the investigators expect that sleep extension across 6 weeks will lower BP, inflammatory (IL-6, CRP, cell adhesion molecules) and autonomic markers (catecholamines). In particular, the investigators expect that in subjects with mild BP elevation, i. e. with pre-hypertension, sleep extension leads to normalization of BP. This study presents a very first approach in using sleep behavior components for the treatment of elevated BP. Therefore, the investigators' second specific aim will characterize the strength of associations between changes in sleep duration, BP, and inflammation, and they will explore factors that are predictive for these changes. In particular, adiposity, as measured by percent body fat, has frequently been shown to be related to short sleep duration and infl
Interventions
- BEHAVIORAL Sleep extension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2005-09 |
| Est. Completion | 2012-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01008176
The ClinicalTrials.gov registry entry for NCT01008176 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sleep extension is the first listed.
NCT01008176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01008176 about?
NCT01008176 is a clinical study titled "Restoring Sleep Homeostasis to Lower Blood Pressure". Cutting back on sleep duration has developed into a common, highly prevalent habit in the adult population, and may lead to a major health problem. Large epidemiological studies have demonstrated that short sleep duration is associated with increased risk of cardiovascular disease (CVD). The investi...
What is the current status of trial NCT01008176?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2005-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01008176?
The interventions under investigation include: Sleep extension (BEHAVIORAL).
Who is sponsoring clinical trial NCT01008176?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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