Clinical trial NCT04017039: Sleep, Blood Pressure and Vascular Health
Official title: Sleep, Blood Pressure and Vascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Sleep
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 107
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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:

1. medical history;
2. physical examination;
3. electrocardiogram and BP at rest and maximal exercise;
4. 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.
5. 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 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)

Primary outcomes:
measure: Phase 1: Systolic Blood Pressure (SBP)
timeFrame: SBP will be measured during Phase 1 at the participants week 1 visit.
measure: Phase 2: Systolic Blood Pressure (SBP)
timeFrame: SBP will be measured during Phase 2 at the participants week 8 visit.
measure: Phase 1: Diastolic Blood Pressure (DBP)
timeFrame: DBP will be measured during Phase 1 at the participants week 1 visit.
measure: Phase 2: Diastolic Blood Pressure (DBP)
timeFrame: DBP wwill be measured during Phase 2 at the participants week 8 visit.
measure: Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
timeFrame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: FBF response to Acetylcholine (ACh)
timeFrame: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
measure: Phase 1: FBF response to Sodium Nitroprusside (NTP)
timeFrame: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: FBF response to Sodium Nitroprusside (NTP)
timeFrame: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
measure: Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
timeFrame: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)
timeFrame: t-PA release will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.
measure: Phase 1: FBF response to L-NMMA
timeFrame: 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.
measure: Phase 2: FBF response to L-NMMA
timeFrame: 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.
measure: Phase 1: FBF response to ACh+L-NMMA
timeFrame: 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.
measure: Phase 2: FBF response to ACh+L-NMMA
timeFrame: 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.
Secondary outcomes:
measure: Phase 1: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: The PSQI questionnaire will be administered during Phase 1 at the participants week 1 visit.
measure: Phase 2: PSQI
timeFrame: The PSQI questionnaire will be administered during Phase 2 at the participants week 8 visit.
measure: Phase 1: Insomnia Severity Index
timeFrame: The insomnia severity index questionnaire will be administered during Phase 1 at the participants week 1 visit.
measure: Phase 2: Insomnia Severity Index
timeFrame: The insomnia severity index questionnaire will be administered during Phase 2 at the participants week 8 visit.
measure: Phase 1: Epworth Sleepiness Scale
timeFrame: The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit.
measure: Phase 2: Epworth Sleepiness Scale
timeFrame: The Epworth Sleepiness scale questionnaire will be administered during Phase 2 at the participants week 8 visit.
Other outcomes:
Locations:
city: Boulder
country: United States
facility: UC-Boulder Clinical and Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christopher DeSouza, PhD
role: PRINCIPAL_INVESTIGATOR
References: