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OpenTrials
Completed

NCT Number: NCT04017039

Sleep, Blood Pressure and Vascular Health

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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Key information

Conditions

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC-Boulder Clinical and Translational Research Center

Boulder, Colorado, 80309, United States

Who can participate

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:

  • 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.

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)

Treatment and study plan

Targeted Sleep Intervention

Other

Primary outcomes

  1. Phase 1: Systolic Blood Pressure (SBP)

    Time frame: SBP will be measured during Phase 1 at the participants week 1 visit.

  2. Phase 2: Systolic Blood Pressure (SBP)

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

    SBP measured following the participants 8 week sleep intervention

  3. Phase 1: Diastolic Blood Pressure (DBP)

    Time frame: DBP will be measured during Phase 1 at the participants week 1 visit.

  4. Phase 2: Diastolic Blood Pressure (DBP)

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

    DBP measured following the participants 8 week sleep intervention

  5. Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)

    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.

  6. Phase 2: FBF response to Acetylcholine (ACh)

    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

  7. Phase 1: FBF response to Sodium Nitroprusside (NTP)

    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.

  8. Phase 2: FBF response to Sodium Nitroprusside (NTP)

    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

  9. Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)

    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.

  10. Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)

    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.

  11. Phase 1: FBF response to L-NMMA

    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.

  12. Phase 2: FBF response to L-NMMA

    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.

  13. Phase 1: FBF response to ACh+L-NMMA

    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.

  14. Phase 2: FBF response to ACh+L-NMMA

    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

Secondary outcomes

  1. Phase 1: Pittsburgh Sleep Quality Index (PSQI)

    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.

  2. Phase 2: PSQI

    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.

  3. Phase 1: Insomnia Severity Index

    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.

  4. Phase 2: Insomnia Severity Index

    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.

  5. Phase 1: Epworth Sleepiness Scale

    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.

  6. Phase 2: Epworth Sleepiness Scale

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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