Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03043963

Collaborator

(none)

188

Enrollment

Location

Arms

64.6

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 10, 2017

Actual Primary Completion Date :

Sep 21, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Reduction in 24 hour blood pressure [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

Lowering of sleep period blood pressure [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator: Janet M Mullington, PhD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Feb 6, 2017

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of May 24, 2022