Elevated Blood Pressure, Habitual Sleep Duration of Less Than or Equal to 7 Hours
Conditions
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.
Interventions
BEHAVIORALSleep extension intervention
Participants will receive a fitbit and 8 weekly sleep-related educational materials via email and telephone coaching to review their sleep tracker data, set goals, trouble shoot any problems, and increase motivation.
BEHAVIORALHealth education
Participants will receive 8 weekly health education newsletters delivered via email.
Sponsors
University of Illinois at Chicago
National Institute of Nursing Research (NINR)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators and outcomes assessors will not have access to the randomization table. Outcomes assessors will not be involved in the group assignments. Participants will be instructed to not tell outcomes assessors which group they are assigned to.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep duration | 8 weeks | Sleep duration will be measured using wrist actigraphy for 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour ambulatory blood pressure | 8 weeks | Ambulatory blood pressure glycemic control, lipids). |
| Sleep duration | 12 months | Sleep duration will be measured using wrist actigraphy for 7 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein (CRP) | 8 weeks | Cardiometabolic marker |
| Diet | 8 weeks | 24 hour diet recall |
| IL-6 | 8 weeks | Cardiometabolic marker |
| Physical activity | 8 weeks | Accelerometer measured activity over 7 days |
| HbA1c | 12 months | Cardiometabolic marker |
Countries
United States
Outcome results
None listed