UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, 80309, United States
NCT Number: NCT04017039
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.
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Notify Me45 year–65 year
All sexes
Interventional
Not applicable
Boulder, Colorado, 80309, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Exclusion criteria
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)
Time frame: SBP will be measured during Phase 1 at the participants week 1 visit.
Time frame: SBP will be measured during Phase 2 at the participants week 8 visit.
SBP measured following the participants 8 week sleep intervention
Time frame: DBP will be measured during Phase 1 at the participants week 1 visit.
Time frame: DBP wwill be measured during Phase 2 at the participants week 8 visit.
DBP measured following the participants 8 week sleep intervention
Time frame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Time frame: 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
Time frame: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Time frame: 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
Time frame: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: The PSQI questionnaire will be administered during Phase 1 at the participants week 1 visit.
This questionnaire assesses sleep quality. Scores range from 0 indicating no difficulty and 21 indicating severe difficulty.
Time frame: The PSQI questionnaire will be administered during Phase 2 at the participants week 8 visit.
This questionnaire assesses sleep quality. Scores range from 0 indicating no difficulty and 21 indicating severe difficulty.
Time frame: The insomnia severity index questionnaire will be administered during Phase 1 at the participants week 1 visit.
This questionnaire is used to assess the nature and severity of insomnia. Scores range from 0 no insomnia to 28 severe insomnia.
Time frame: The insomnia severity index questionnaire will be administered during Phase 2 at the participants week 8 visit.
This questionnaire is used to assess the nature and severity of insomnia. Scores range from 0 no insomnia to 28 severe insomnia.
Time frame: The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit.
This questionnaire is used to assess daytime sleepiness. Scores range from 0 normal daytime sleepiness to 24 severe daytime sleepiness.
Time frame: The Epworth Sleepiness scale questionnaire will be administered during Phase 2 at the participants week 8 visit.
This questionnaire is used to assess daytime sleepiness. Scores range from 0 normal daytime sleepiness to 24 severe daytime sleepiness.
University of Colorado, Boulder
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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