NCT02929810已完成不适用
Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- change in 24-hour mean arterial pressure
研究概览
简要总结
Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.
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
- Single (Investigator)
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
- •Presence of either:
- •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
- •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
- •Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders
- •If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
- •Habitual sleep duration ≥7 hours
- •Excessive alcohol (≥15 drinks/week in men and ≥8 drinks/week in women) and/or excessive caffeine intake (>400 mg)
- •Currently on a diet and/or actively trying to lose weight
- •Currently or previously (during the past 2 months) participation in any other research study 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 extension
Experimental
干预措施: sleep extension (Behavioral)
sleep maintenance
Active Comparator
干预措施: sleep maintenance (Behavioral)
结局指标
主要结局
change in 24-hour mean arterial pressure
时间窗: 8 weeks
次要结局
- change in endothelial function(8 weeks)
- change in insulin sensitivity(8 weeks)
- change in baroreflex sensitivity(8 weeks)
研究者
Virend Somers, MD, PhD
Professor of Medicine
Mayo Clinic
研究点 (1)
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