Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
- Conditions
- Sleep Apnea
- Interventions
- Device: PAP
- Registration Number
- NCT04575740
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes.
One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the "apnea-hypopnea index (AHI)", there is a potential risk of negative results.
In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia ("hypoxic burden"), autonomic response ("heart rate burden"), and sleep fragmentation ("arousal burden").
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 158
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Positive Airway Pressure Device PAP All participants will receive PAP therapy
- Primary Outcome Measures
Name Time Method Change from baseline 24-hour mean systolic blood pressure at 12 weeks 12 weeks Mean systolic blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
Change from baseline Epworth Sleepiness Scale (ESS) at 12 weeks 12 weeks Self-reported sleepiness measured using the Epworth Sleepiness Scale (units on a scale). Values range from 0-24; higher values indicate greater sleepiness.
Change from baseline flow-mediated vasodilation at 12 weeks 12 weeks Flow mediated vasodilation is studied using high resolution ultrasound of the artery.
- Secondary Outcome Measures
Name Time Method Change from baseline Albumin without Creatinine at 12 weeks 12 weeks Urinary Albumin is calculated from urine samples.
Change from baseline Plasminogen Activator Inhibitor-1 at 12 weeks 12 weeks Plasminogen activator inhibitor type 1 (PAI-1) measurements are calculated through fasting phlebotomy.
Change from baseline Creatinine at 12 weeks 12 weeks Creatinine is calculated from blood samples collected through fasting phlebotomy
Change from baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) at 12 weeks 12 weeks N-terminal pro b-type natriuretic peptide (NT-proBNP) measurements are calculated through fasting phlebotomy.
Change from baseline Albumin/Creatinine Ratio at 12 weeks 12 weeks Urinary Albumin/Creatinine Ratio is calculated from urine samples.
Change from baseline Hemoglobin A1c (HbA1c) at 12 weeks 12 weeks Hemoglobin A1c (HbA1c) measurements are calculated through fasting phlebotomy.
Change from baseline high sensitivity C-Reactive Protein (hs-CRP) at 12 weeks 12 weeks C-reactive protein measurements are calculated from blood samples collected through fasting phlebotomy.
Change from baseline Fibrinogen Antigen at 12 weeks 12 weeks Fibrinogen Antigen measurements are calculated through fasting phlebotomy. High values indicate inflammation and increased risk of atherosclerosis.
Change from baseline Cystanin C with eGFR at 12 weeks 12 weeks Cystanin C with eGFR is calculated from blood samples collected through fasting phlebotomy
Change from baseline nocturnal mean diastolic blood pressure at 12 weeks 12 weeks Mean diastolic blood pressure during sleep is measured using an ambulatory blood pressure monitor.
Change from baseline Psychomotor Vigilance Task reaction time at 12 weeks 12 weeks 3-minute Psychomotor Vigilance Tasks will be done to quantify the speed with which subjects respond to a visual stimulus.
Change from baseline F2-Isoprostane/Creatinine Ratio at 12 weeks 12 weeks F2-Isoprostane/Creatinine Ratio, a measure of oxidative stress, is calculated from urine sample.
Change from baseline Oxidized low-density lipoprotein (LDL) at 12 weeks 12 weeks Oxidized low-density lipoprotein measurements are calculated through fasting phlebotomy.
Change from baseline lipid panel at 12 weeks 12 weeks Lipid panel measurements are calculated from blood samples collected through fasting phlebotomy.
Change from baseline nocturnal mean systolic blood pressure at 12 weeks 12 weeks Mean systolic blood pressure during sleep is measured using an ambulatory blood pressure monitor.
Change from baseline nocturnal mean blood pressure at 12 weeks 12 weeks Mean arterial blood pressure during sleep is measured using an ambulatory blood pressure monitor.
Change from baseline Glucose at 12 weeks 12 weeks Blood glucose measurements are calculated through fasting phlebotomy
Change from baseline Interleukin-6 (IL-6) at 12 weeks 12 weeks IL-6 is calculated from blood samples collected through fasting phlebotomy
Change from baseline 24-hour mean diastolic blood pressure at 12 weeks 12 weeks Mean diastolic blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
Change from baseline 24-hour mean blood pressure at 12 weeks 12 weeks Mean arterial blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
Change from baseline Functional Outcome of Sleep Questionnaire (FOSQ) at 12 weeks 12 weeks This test will be used to assess the impact of excessive sleepiness on functional outcomes relevant to daily behaviors and sleep-related quality of life.
Change from baseline Psychomotor Vigilance Task lapses per test at 12 weeks 12 weeks 3-minute Psychomotor Vigilance Tasks will be done to quantify the speed with which subjects respond to a visual stimulus.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States