Sleep, Blood Pressure and Vascular Health

Sleep Clinical Trial

Official title:

Sleep, Blood Pressure and Vascular Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017039
• Other study ID #: 160646
• Status: Completed
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: May 2023

Study information

• Verified date: November 2023
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: May 2023
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Pressure
• Sleep

Intervention

Other:
• Targeted Sleep Intervention

Locations

Country	Name	City	State
United States	UC-Boulder Clinical and Translational Research Center	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Systolic Blood Pressure (SBP)		SBP will be measured during Phase 1 at the participants week 1 visit.
Primary	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.
Primary	Phase 1: Diastolic Blood Pressure (DBP)		DBP will be measured during Phase 1 at the participants week 1 visit.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Phase 1: Pittsburgh Sleep Quality Index (PSQI)	This questionnaire assesses sleep quality. Scores range from 0 indicating no difficulty and 21 indicating severe difficulty.	The PSQI questionnaire will be administered during Phase 1 at the participants week 1 visit.
Secondary	Phase 2: PSQI	This questionnaire assesses sleep quality. Scores range from 0 indicating no difficulty and 21 indicating severe difficulty.	The PSQI questionnaire will be administered during Phase 2 at the participants week 8 visit.
Secondary	Phase 1: Insomnia Severity Index	This questionnaire is used to assess the nature and severity of insomnia. Scores range from 0 no insomnia to 28 severe insomnia.	The insomnia severity index questionnaire will be administered during Phase 1 at the participants week 1 visit.
Secondary	Phase 2: Insomnia Severity Index	This questionnaire is used to assess the nature and severity of insomnia. Scores range from 0 no insomnia to 28 severe insomnia.	The insomnia severity index questionnaire will be administered during Phase 2 at the participants week 8 visit.
Secondary	Phase 1: Epworth Sleepiness Scale	This questionnaire is used to assess daytime sleepiness. Scores range from 0 normal daytime sleepiness to 24 severe daytime sleepiness.	The Epworth Sleepiness scale questionnaire will be administered during Phase 1 at the participants week 1 visit.
Secondary	Phase 2: Epworth Sleepiness Scale	This questionnaire is used to assess daytime sleepiness. Scores range from 0 normal daytime sleepiness to 24 severe daytime sleepiness.	The Epworth Sleepiness scale questionnaire will be administered during Phase 2 at the participants week 8 visit.