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Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep

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: NCT03043963
Recruitment Status : Active, not recruiting
First Posted : February 6, 2017
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Janet M Mullington, PhD, Beth Israel Deaconess Medical Center

Brief Summary:
The main purpose of this study is to learn about the influence of two different behavioral interventions (lasting 8 weeks) involving sleep for lowering blood pressure, and to study the mechanisms involved. There is research evidence that healthy sleep promotes heart-health and may decrease blood pressure, and that sensitivity to insufficient or disrupted sleep may be influenced by sex. This research will compare two interventions that are each designed to improve sleep health, and will investigate sex differences in response. The project includes 3 in-hospital stays with biological measurements to evaluate the underlying mechanisms associated with the effectiveness of two different blood pressure lowering behavioral interventions.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Sleep Extension Behavioral: Sleep Timing Not Applicable

Detailed Description:
The study involves home-based sleep-wake data collection before and during behavioral intervention, and 3 overnight stays in the hospital. For each hospital stay participants will be asked to arrive in the afternoon, and stay until the next evening. They will be provided dinner on the first day and breakfast, lunch and dinner on the second day. If they are taking any blood pressure medication they will continue to take it through the study. During the in-hospital stays, blood pressure will be measured continuously using two small finger cuffs. In order to monitor and record brain waves to determine sleep and wakefulness, small gold-coated disks called electrodes will be placed on the head and body. Heart rate, blood pressure and brain activity will be recorded for a little over 24 hours on each in-hospital stay. Before as well as during the in-hospital stays questions will be asked about sleep times, subjective sleepiness and other indices relating to well-being.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep Extension
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : September 21, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sleep Timing
Intervention will include basic education concerning sleep hygiene and regularity of sleep timing
Behavioral: Sleep Timing
Regularize the timing of the sleep period.

Experimental: Sleep Extension
Intervention will include basic education concerning sleep hygiene and an extension of the sleep period.
Behavioral: Sleep Extension
Lengthen the duration of sleep time.




Primary Outcome Measures :
  1. Reduction in 24 hour blood pressure [ Time Frame: The primary outcome measure will be measured during 3 hospital visit periods of approximately 28 hours each. The primary outcome will be evaluated based on an 8 week behavioral intervention. ]
    24h blood pressure (daily averaged).


Secondary Outcome Measures :
  1. Lowering of sleep period blood pressure [ Time Frame: he primary outcome measure will be measured during 3 hospital visit periods ofThe secondary outcome will be evaluated based on an 8 week behavioral intervention. ]
    Blood pressure during day wake period minus blood pressure at night during sleep period



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pre-hypertension or stage one hypertension (BP ≥120/80 and <160/100).
  • usual sleep period occurs at night

Exclusion Criteria:

  • significant active or uncontrolled sleep disorders
  • shiftwork
  • current pregnancy
  • diabetic patients who are insulin dependent (or have HbA1c>9.0%)
  • current use of hypnotics or clonidine
  • renal/electrolyte disorders and any other condition that the study screening physician considers would significantly impede participation in the study

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): NCT03043963


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: Janet M Mullington, PhD Beth Israel Deaconess Medical Center
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Responsible Party: Janet M Mullington, PhD, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03043963    
Other Study ID Numbers: 2015P000243
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases