Restoring Sleep Homeostasis to Lower Blood Pressure
Primary Purpose
Hypertension, Pre-hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep extension
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Sleep, Blood Pressure, Inflammatory Markers
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
Outcomes
Primary Outcome Measures
Change in blood pressure
Secondary Outcome Measures
Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine)
Full Information
NCT ID
NCT01008176
First Posted
October 20, 2009
Last Updated
March 10, 2017
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01008176
Brief Title
Restoring Sleep Homeostasis to Lower Blood Pressure
Official Title
Restoring Sleep Homeostasis to Lower Blood Pressure: A Behavioral Prevention and Treatment Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pre-hypertension
Keywords
Hypertension, Sleep, Blood Pressure, Inflammatory Markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension
Intervention Description
Habitual sleep duration is extended by 60min/night over a 6-week time period.
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in inflammatory and autonomic markers (IL-6, CRP, norepinephrine)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
haack monika, md
Organizational Affiliation
doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23171375
Citation
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.
Results Reference
derived
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Restoring Sleep Homeostasis to Lower Blood Pressure
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