Mechanisms Underlying the Blood Pressure Lowering Effect of Sleep

NCT03043963 | Completed

• 1 other identifier: 2015P000243
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Reduction in 24 hour blood pressure

  24h blood pressure (daily averaged).

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Sleep Timing

ACTIVE COMPARATOR

Intervention will include basic education concerning sleep hygiene and regularity of sleep timing

Behavioral: Sleep Timing

Sleep Extension

EXPERIMENTAL

Intervention will include basic education concerning sleep hygiene and an extension of the sleep period.

Behavioral: Sleep Extension

Interventions

Sleep Extension BEHAVIORAL

Lengthen the duration of sleep time.

Sleep Extension

Sleep Timing BEHAVIORAL

Regularize the timing of the sleep period.

Sleep Timing

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Janet M Mullington, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: February 10, 2017
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)