Effects of a Behavioral Sleep Extension Intervention on Cardiometabolic Risk Factors Among Patients With Elevated BP/Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Sleep duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sleep duration
时间窗: 8 weeks
Sleep duration will be measured using wrist actigraphy for 7 days
次要结局
- 24 hour ambulatory blood pressure(12 months)
- Sleep duration(12 months)
研究者
Kelly Glazer Baron
Professor
University of Utah