Elevated Blood Pressure Clinical Trial
— STITCHOfficial title:
Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
Verified date | May 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | May 30, 2025 |
Est. primary completion date | June 10, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institute of Nursing Research (NINR), University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Diet | 24 hour diet recall | 8 weeks | |
Other | Diet | 24 hour diet recall | 12 months | |
Other | Physical activity | Accelerometer measured activity over 7 days | 8 weeks | |
Other | Physical activity | Accelerometer measured activity over 7 days | 12 months | |
Other | HbA1c | Cardiometabolic marker | 12 months | |
Other | C-reactive protein (CRP) | Cardiometabolic marker | 8 weeks | |
Other | C-reactive protein (CRP) | Cardiometabolic marker | 12 months | |
Other | IL-6 | Cardiometabolic marker | 8 weeks | |
Other | IL-6 | Cardiometabolic marker | 12 months | |
Primary | Sleep duration | Sleep duration will be measured using wrist actigraphy for 7 days | 8 weeks | |
Secondary | 24 hour ambulatory blood pressure | Ambulatory blood pressure glycemic control, lipids). | 8 weeks | |
Secondary | 24 hour ambulatory blood pressure | Ambulatory blood pressure glycemic control, lipids). | 12 months | |
Secondary | Sleep duration | Sleep duration will be measured using wrist actigraphy for 7 days | 12 months |
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