Status:
COMPLETED
Sleep, Blood Pressure and Vascular Health
Lead Sponsor:
University of Colorado, Boulder
Conditions:
Blood Pressure
Sleep
Eligibility:
All Genders
45-65 years
Phase:
NA
Brief Summary
The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
November 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04017039
Start Date
November 10 2016
End Date
May 1 2023
Last Update
November 30 2023
Active Locations (1)
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1
UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, United States, 80309