Blood Pressure, Sleep
Conditions
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.
Interventions
OTHERTargeted Sleep Intervention
Sponsors
University of Colorado, Boulder
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: FBF response to ACh+L-NMMA | 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 |
| Phase 2: FBF response to Sodium Nitroprusside (NTP) | 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) | 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) | 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 | 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 | 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 | 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) | SBP will be measured during Phase 1 at the participants week 1 visit. | — |
| Phase 2: Systolic Blood Pressure (SBP) | 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) | DBP will be measured during Phase 1 at the participants week 1 visit. | — |
| Phase 2: Diastolic Blood Pressure (DBP) | DBP wwill be measured during Phase 2 at the participants week 8 visit. | DBP measured following the participants 8 week sleep intervention |
| Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh) | 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 2: FBF response to Acetylcholine (ACh) | 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 1: FBF response to Sodium Nitroprusside (NTP) | FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: PSQI | 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. |
| Phase 1: Insomnia Severity Index | 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. |
| Phase 2: Insomnia Severity Index | 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. |
| Phase 1: Epworth Sleepiness Scale | 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. |
| Phase 2: Epworth Sleepiness Scale | 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. |
| Phase 1: Pittsburgh Sleep Quality Index (PSQI) | 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. |
Countries
United States
Outcome results
None listed