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Restoring Sleep Homeostasis to Lower Blood Pressure

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ClinicalTrials.gov Identifier: NCT01008176
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Monika Haack, Beth Israel Deaconess Medical Center

Brief 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 inflammatory processes, but the role of adiposity in modulating the physiological consequences of changes in sleep duration has never been addressed.

If the investigators' hypothesis is correct, sleep extension may be considered as an additional component in current lifestyle intervention programs in combating and preventing hypertension.


Condition or disease Intervention/treatment Phase
Hypertension Pre-hypertension Behavioral: Sleep extension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Restoring Sleep Homeostasis to Lower Blood Pressure: A Behavioral Prevention and Treatment Approach
Study Start Date : September 2005
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Sleep extension
    Habitual sleep duration is extended by 60min/night over a 6-week time period.


Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current history of prehypertension or stage 1 hypertension
  • Sleep duration <= 7 hours/night

Exclusion Criteria:

  • Sleep disorders
  • History of psychiatric or severe medical disorders
  • regular medication intake, except anti-hypertensive and birth control medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008176


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: haack monika, md doctor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Monika Haack, Assistant Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01008176    
Other Study ID Numbers: 2005P000246
First Posted: November 5, 2009    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Keywords provided by Monika Haack, Beth Israel Deaconess Medical Center:
Hypertension
Sleep
Blood Pressure
Inflammatory Markers
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases