Sleep, Blood Pressure and Vascular Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
研究概览
简要总结
The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Furthermore, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in adults with elevated blood pressure. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
- •All women will be premenopausal, perimenopausal or post-menopausal not taking hormone replacement therapy.
- •Subjects will be prehypertensive/hypertensive (Stage 1 hypertension) defined as resting systolic blood pressure 125-159 mmHg and/or diastolic blood pressure 75-99 mmHg.
- •Subjects will have no overt signs of disease as assessed by:
- •medical history;
- •physical examination;
- •electrocardiogram and BP at rest and maximal exercise;
- •sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.
- •Subjects that have a pre-existing diagnosis of obstructive sleep apnea, or are determined to have obstructive sleep apnea based on their sleep disorders screening visit will be allowed in the study, but will not take part in the sleep intervention/post sleep intervention visits.
排除标准
- •History of stroke (phone screen and medical record) Peripheral vascular disease (phone screen and medical record) History of anaphylaxis to betadine, lidocaine, iodine Body mass index > 40 kg/m2
- •Subjects taking blood pressure-or diabetes related medication Chronic Insomnia (prior or current diagnosis) History of or current psychiatric disorder (e.g., prior or current diagnosis, current BDI-II>13; BAI>10) Significant organ system dysfunction/disease (e.g. diabetes, severe pulmonary, kidney disease) History of seizure disorder Pregnant/nursing Positive toxicology screen-(THC, OPI, AMP, COC, PCP, BAR, BZO, MAMP/MDMA upon sleep lab admission)
结局指标
主要结局
Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
时间窗: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 1: FBF response to Sodium Nitroprusside (NTP)
时间窗: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: FBF response to Sodium Nitroprusside (NTP)
时间窗: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
FBF to NTP will be measured following the participants 8 week sleep intervention
Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
时间窗: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)
时间窗: t-PA release will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
Endothelial t-PA release will be measured following the participants 8 week sleep intervention.
Phase 1: FBF response to L-NMMA
时间窗: FBF response to L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 2: FBF response to L-NMMA
时间窗: FBF response to L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
FBF to L-NMMA will be measured following the participants 8 week sleep intervention.
Phase 1: FBF response to ACh+L-NMMA
时间窗: FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Phase 1: Systolic Blood Pressure (SBP)
时间窗: SBP will be measured during Phase 1 at the participants week 1 visit.
Phase 2: Systolic Blood Pressure (SBP)
时间窗: SBP will be measured during Phase 2 at the participants week 8 visit.
SBP measured following the participants 8 week sleep intervention
Phase 1: Diastolic Blood Pressure (DBP)
时间窗: DBP will be measured during Phase 1 at the participants week 1 visit.
Phase 2: Diastolic Blood Pressure (DBP)
时间窗: DBP wwill be measured during Phase 2 at the participants week 8 visit.
DBP measured following the participants 8 week sleep intervention
Phase 2: FBF response to Acetylcholine (ACh)
时间窗: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
FBF to ACh will be measured following the participants 8 week sleep intervention
Phase 2: FBF response to ACh+L-NMMA
时间窗: FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
FBF to ACh+L-NMMA will be measured following the participants 8 week sleep intervention
次要结局
- Phase 1: Insomnia Severity Index(The insomnia severity index questionnaire will be administered during Phase 1 at the participants week 1 visit.)
- Phase 2: Insomnia Severity Index(The insomnia severity index questionnaire will be administered during Phase 2 at the participants week 8 visit.)
- Phase 1: Pittsburgh Sleep Quality Index (PSQI)(The PSQI questionnaire will be administered during Phase 1 at the participants week 1 visit.)
- Phase 2: PSQI(The PSQI questionnaire will be administered during Phase 2 at the participants week 8 visit.)
- Phase 1: Epworth Sleepiness Scale(The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit.)
- Phase 2: Epworth Sleepiness Scale(The Epworth Sleepiness scale questionnaire will be administered during Phase 2 at the participants week 8 visit.)
研究者
Christopher DeSouza
Professor
University of Colorado, Boulder