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Clinical Trials/NCT04766424
NCT04766424
Active, not recruiting
Not Applicable

Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension

University of Utah1 site in 1 country120 target enrollmentMarch 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elevated Blood Pressure
Sponsor
University of Utah
Enrollment
120
Locations
1
Primary Endpoint
Sleep duration
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.

Detailed Description

Half of U.S. adults have at least one cardio-metabolic disease (CMD), including hypertension (HTN), heart disease, stroke, or diabetes. Even with advances in screening, education, and medication management, controlling these chronic diseases remains challenging. Despite the well-established negative effects of short sleep duration, surprisingly few studies have tested the benefits of sleep extension and even fewer studies evaluate the science of sleep extension interventions. Therefore, the goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, CMD risk factors, and health behaviors among adults with elevated BP/HTN and short sleep duration.

Registry
clinicaltrials.gov
Start Date
March 30, 2021
End Date
June 14, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly Glazer Baron

Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • Age 18-65
  • 24h ABP readings indicating elevated blood pressure (BP) or hypertension (24h average systolic (SBP) of 115-145 mmHg or diastolic (DBP) of 75-90 mmHg). Patients taking antihypertensive medications will be permitted if stable dose for \>8 weeks
  • Time in bed \<8 hours and habitual sleep duration \<7 hours via actigraphy;
  • Smartphone user
  • Able to read/write in English.

Exclusion Criteria

  • High risk or presence of moderate to severe comorbid sleep disorders (i.e., obstructive sleep apnea AHI 15 or greater, restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight obstructive sleep apnea at the baseline/screening
  • Resistant hypertension, defined as \>4 antihypertensive medications or taking medications and standardized in lab BP \>130 mmHg SBP or 80 mmHg DBP at screening History of cognitive or neurological disorders (e.g. dementia, Parkinson's, Multiple Sclerosis)
  • BMI\>50 kg/m2 or arm circumference greater than extra large cuff
  • Presence of major psychiatric disorders (e.g. schizophrenia, bipolar disorder)
  • alcohol abuse on the Audit-C (score \>4 for men, \>3 for women)
  • drug use on the NIDA-Modified ASSIST (score \>3),90
  • moderate to severe depressive symptoms (PHQ-8 \>10)
  • Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis)
  • Overnight work more than 1x per month
  • Use of hypnotic or stimulant medications

Outcomes

Primary Outcomes

Sleep duration

Time Frame: 8 weeks

Sleep duration will be measured using wrist actigraphy for 7 days

Secondary Outcomes

  • 24 hour ambulatory blood pressure(12 months)
  • Sleep duration(12 months)

Study Sites (1)

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