Clinical trial NCT04766424: Sleep Technology Intervention to Target Cardiometabolic Health
Official title: Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Elevated Blood Pressure
Habitual Sleep Duration of Less Than or Equal to 7 Hours
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: National Institute of Nursing Research (NINR)
First posted: 2021-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* Situations that would significantly impact the ability to extend sleep, including overnight caregiving responsibility for children under the age 1, elderly or disabled adults \>1x per week
* Inability to read or write in English
* Pregnancy/desire to become pregnant during the study period.

Primary outcomes:
measure: Sleep duration
timeFrame: 8 weeks
Secondary outcomes:
measure: 24 hour ambulatory blood pressure
timeFrame: 8 weeks
measure: 24 hour ambulatory blood pressure
timeFrame: 12 months
measure: Sleep duration
timeFrame: 12 months
Other outcomes:
measure: Diet
timeFrame: 8 weeks
measure: Diet
timeFrame: 12 months
measure: Physical activity
timeFrame: 8 weeks
measure: Physical activity
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: C-reactive protein (CRP)
timeFrame: 8 weeks
measure: C-reactive protein (CRP)
timeFrame: 12 months
measure: IL-6
timeFrame: 8 weeks
measure: IL-6
timeFrame: 12 months
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: