Sleep, Blood Pressure and Vascular Health

NCT04017039 | Completed DMC

• 1 other identifier: 160646
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Sleep

Outcome Measures

Primary Outcomes (14)

• 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 measured following the participants 8 week sleep intervention

  SBP will be measured during Phase 2 at the participants week 8 visit.

• 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 measured following the participants 8 week sleep intervention

  DBP wwill be measured during Phase 2 at the participants week 8 visit.

• 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 to ACh will be measured following the participants 8 week sleep intervention

  FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.

• 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.

• Phase 2: FBF response to Sodium Nitroprusside (NTP)

  FBF to NTP will be measured following the participants 8 week sleep intervention

  FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.

• 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)

  Endothelial t-PA release will be measured following the participants 8 week sleep intervention.

  t-PA release will be measured during Phase 2 at the participants visit 9 which is ~13 weeks from their respective start date.

• 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 to L-NMMA will be measured following the participants 8 week sleep intervention.

  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.

• 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 2: FBF response to ACh+L-NMMA

  FBF to ACh+L-NMMA will be measured following the participants 8 week sleep intervention

  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 (6)

• 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: 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: Epworth Sleepiness Scale

  The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit.

Study Arms (2)

Phase 1

NO INTERVENTION

Phase I is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 6.5 hr/night (short sleep)

Phase 2

EXPERIMENTAL

Phase II is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in adults with elevated blood pressure who habitually sleep less than 6.5 hr/night (Specific Aims 3).

Other: Targeted Sleep Intervention

Interventions

Targeted Sleep Intervention OTHER

Phase 2

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

UC-Boulder Clinical and Translational Research Center

Boulder, Colorado, 80309, United States

Location

Study Officials

• Christopher DeSouza, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 12, 2019
• Study Start: November 10, 2016
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

US (1)