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Restoring Sleep Homeostasis to Lower Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 20, 2009
First Posted Date  ICMJE November 5, 2009
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE September 2005
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
Change in blood pressure [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2009)
Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine) [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restoring Sleep Homeostasis to Lower Blood Pressure
Official Title  ICMJE Restoring Sleep Homeostasis to Lower Blood Pressure: A Behavioral Prevention and Treatment Approach
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Pre-hypertension
Intervention  ICMJE Behavioral: Sleep extension
Habitual sleep duration is extended by 60min/night over a 6-week time period.
Study Arms  ICMJE Not Provided
Publications * Haack M, Serrador J, Cohen D, Simpson N, Meier-Ewert H, Mullington JM. Increasing sleep duration to lower beat-to-beat blood pressure: a pilot study. J Sleep Res. 2013 Jun;22(3):295-304. doi: 10.1111/jsr.12011. Epub 2012 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2014)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2009)
60
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008176
Other Study ID Numbers  ICMJE 2005P000246
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monika Haack, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: haack monika, md doctor
PRS Account Beth Israel Deaconess Medical Center
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP