HELP-HY: Health Education and sLeep Program in HYpertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- change in 48-hour mean arterial pressure
研究概览
简要总结
Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed.
In this study the investigators aim to investigate the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).
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)
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 to 65 (inclusive)
- •Gender: both males and females
- •Body mass index (BMI): 18.5-34.9 kg/m2
- •Habitual sleep duration <7 hours and voluntary prolongation of sleep when circumstances allow (as indicated by napping and/or >45 min catch-up sleep during weekends or holidays)
- •Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg) , Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99 mmHg ) , or currently taking antihypertensive medications
- •Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
- •Not pregnant or breast feeding and not intending to become pregnant or breast feed
- •Not a current smoker or tobacco user
- •Ability to provide written informed consent.
排除标准
- •Vulnerable study populations will be excluded
- •Pregnancy
- •Shift-work
- •Travel across >2 time zones in the previous month
- •Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep/circadian disorders, psychiatric disorders
- •If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
- •Sleep aids
- •Habitual sleep duration ≥7 hours
- •Excessive alcohol (>14 drinks/week in men and >7 drinks/week in women) and/or excessive caffeine intake (>400 mg)
- •Currently on a diet and/or actively trying to lose weight
- •History of drowsing driving
- •Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale)
- •Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel
- •Blood/plasma donation during the past 2 months
- •Unwillingness or inability to adjust sleep schedule
研究组 & 干预措施
Sleep Enhancement
干预措施: Sleep Enhancement (Behavioral)
Health Education
干预措施: Health Education (Behavioral)
结局指标
主要结局
change in 48-hour mean arterial pressure
时间窗: 8 weeks
changes in ambulatory measure of blood pressure
次要结局
- changes in endothelial function(8 weeks)
- changes in cortisol(8 weeks)
- changes in catecholamines(8 weeks)
- changes in angiotensin peptides(8 weeks)
- changes in baroreflex sensitivity(8 weeks)
- changes in 48-hour heart rate(8 weeks)
- changes in renin(8 weeks)
- changes in aldosterone(8 weeks)
- changes in insulin sensitivity(8 weeks)
- changes in body fat(8 weeks)
研究者
Virend Somers, MD, PhD
Professor of Medicine
Mayo Clinic