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出境医 / 临床实验 / Sleep, Blood Pressure and Vascular Health
Sleep, Blood Pressure and Vascular Health
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blood Pressure Sleep | Other: Targeted Sleep Intervention | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Sleep, Blood Pressure and Vascular Health |
| Actual Study Start Date : | November 10, 2016 |
| Estimated Primary Completion Date : | November 2021 |
| Estimated Study Completion Date : | December 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Phase 1
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)
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Experimental: Phase 2
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).
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Other: Targeted Sleep Intervention |
Outcome Measures
Primary Outcome Measures :
- Phase 1: Systolic Blood Pressure (SBP) [ Time Frame: SBP will be measured during Phase 1 at the participants week 1 visit. ]
- 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
- Phase 1: Diastolic Blood Pressure (DBP) [ Time Frame: DBP will be measured during Phase 1 at the participants week 1 visit. ]
- 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
- Phase 1: Sleep [ Time Frame: PSG and sleep questionnaires will be measured during Phase 1 at the participants visit 4 which is ~4 weeks from their respective start date. ]Measured using Polysomnography (PSG) Assessment
- Phase 2: Sleep [ Time Frame: PSG and sleep questionnaires will be measured during Phase 2 at the participants visit 8 which is ~12 weeks from their respective start date. ]Measured using Polysomnography (PSG) Assessment following the participants 8 week sleep intervention.
- 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. ]
- 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
- 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. ]
- 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
- 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. ]
- 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.
- 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. ]
- 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.
- 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. ]
- 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 Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- 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)
Contacts and Locations
Locations
| United States, Colorado | |
| UC-Boulder Clinical and Translational Research Center | |
| Boulder, Colorado, United States, 80309 | |
Sponsors and Collaborators
University of Colorado, Boulder
Investigators
| Principal Investigator: | Christopher DeSouza, PhD | University of Colorado, Denver |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 2, 2019 | ||||
| First Posted Date ICMJE | July 12, 2019 | ||||
| Last Update Posted Date | May 21, 2021 | ||||
| Actual Study Start Date ICMJE | November 10, 2016 | ||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sleep, Blood Pressure and Vascular Health | ||||
| Official Title ICMJE | Sleep, Blood Pressure and Vascular Health | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Targeted Sleep Intervention | ||||
| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||
| Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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:
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) |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 45 Years to 65 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04017039 | ||||
| Other Study ID Numbers ICMJE | 160646 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Christopher DeSouza, University of Colorado, Boulder | ||||
| Study Sponsor ICMJE | University of Colorado, Boulder | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | University of Colorado, Boulder | ||||
| Verification Date | May 2021 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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