- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575740
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
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").
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nkiru G Ujomu
- Phone Number: 617-732-8976
- Email: nujomu@bwh.harvard.edu
Study Contact Backup
- Name: Kiley E Blodgett
- Phone Number: 617-732-8976
- Email: keblodgett@bwh.harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Nkiru G Ujomu
- Phone Number: 617-732-8976
- Email: nujomu@bwh.harvard.edu
-
Contact:
- Kiley Blodgett
- Email: keblodgett@bwh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Adults aged 21-80 years.
- Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation.
Exclusion criteria:
- Current treatment for obstructive sleep apnea (including CPAP, oral appliances, supplemental oxygen). Patients must be untreated prior to the baseline visit.
- Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon).
- Active use of non-prescription opioids (e.g., cocaine, methamphetamine)
- Uncontrolled medical problem or major organ system disease, which, in the opinion of the investigators (PI and Co-Is), would interfere with the evaluation of the subject (e.g., uncontrolled hypertension, unstable coronary heart disease, etc.).
- History of congestive heart failure, renal insufficiency, systemic neurological condition that could affect respiration.
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
- central sleep apnea (>50% of respiratory events scored as central),
- chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
- Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
- Patients unable or unwilling to use CPAP.
- Insomnia or insufficient sleep (self-reported inability to sleep >6 hrs night).
- Pregnancy (women)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Positive Airway Pressure Device
All participants will receive PAP therapy
|
Positive airway pressure to treat sleep apnea
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline flow-mediated vasodilation at 12 weeks
Time Frame: 12 weeks
|
Flow mediated vasodilation is studied using high resolution ultrasound of the artery.
|
12 weeks
|
Change from baseline 24-hour mean systolic blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean systolic blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline Epworth Sleepiness Scale (ESS) at 12 weeks
Time Frame: 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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline F2-Isoprostane/Creatinine Ratio at 12 weeks
Time Frame: 12 weeks
|
F2-Isoprostane/Creatinine Ratio, a measure of oxidative stress, is calculated from urine sample.
|
12 weeks
|
Change from baseline Albumin/Creatinine Ratio at 12 weeks
Time Frame: 12 weeks
|
Urinary Albumin/Creatinine Ratio is calculated from urine samples.
|
12 weeks
|
Change from baseline Albumin without Creatinine at 12 weeks
Time Frame: 12 weeks
|
Urinary Albumin is calculated from urine samples.
|
12 weeks
|
Change from baseline Oxidized low-density lipoprotein (LDL) at 12 weeks
Time Frame: 12 weeks
|
Oxidized low-density lipoprotein measurements are calculated through fasting phlebotomy.
|
12 weeks
|
Change from baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) at 12 weeks
Time Frame: 12 weeks
|
N-terminal pro b-type natriuretic peptide (NT-proBNP) measurements are calculated through fasting phlebotomy.
|
12 weeks
|
Change from baseline Hemoglobin A1c (HbA1c) at 12 weeks
Time Frame: 12 weeks
|
Hemoglobin A1c (HbA1c) measurements are calculated through fasting phlebotomy.
|
12 weeks
|
Change from baseline Plasminogen Activator Inhibitor-1 at 12 weeks
Time Frame: 12 weeks
|
Plasminogen activator inhibitor type 1 (PAI-1) measurements are calculated through fasting phlebotomy.
|
12 weeks
|
Change from baseline Fibrinogen Antigen at 12 weeks
Time Frame: 12 weeks
|
Fibrinogen Antigen measurements are calculated through fasting phlebotomy.
High values indicate inflammation and increased risk of atherosclerosis.
|
12 weeks
|
Change from baseline Glucose at 12 weeks
Time Frame: 12 weeks
|
Blood glucose measurements are calculated through fasting phlebotomy
|
12 weeks
|
Change from baseline high sensitivity C-Reactive Protein (hs-CRP) at 12 weeks
Time Frame: 12 weeks
|
C-reactive protein measurements are calculated from blood samples collected through fasting phlebotomy.
|
12 weeks
|
Change from baseline Interleukin-6 (IL-6) at 12 weeks
Time Frame: 12 weeks
|
IL-6 is calculated from blood samples collected through fasting phlebotomy
|
12 weeks
|
Change from baseline Creatinine at 12 weeks
Time Frame: 12 weeks
|
Creatinine is calculated from blood samples collected through fasting phlebotomy
|
12 weeks
|
Change from baseline Cystanin C with eGFR at 12 weeks
Time Frame: 12 weeks
|
Cystanin C with eGFR is calculated from blood samples collected through fasting phlebotomy
|
12 weeks
|
Change from baseline lipid panel at 12 weeks
Time Frame: 12 weeks
|
Lipid panel measurements are calculated from blood samples collected through fasting phlebotomy.
|
12 weeks
|
Change from baseline 24-hour mean diastolic blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean diastolic blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline 24-hour mean blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean arterial blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline nocturnal mean systolic blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean systolic blood pressure during sleep is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline nocturnal mean diastolic blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean diastolic blood pressure during sleep is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline nocturnal mean blood pressure at 12 weeks
Time Frame: 12 weeks
|
Mean arterial blood pressure during sleep is measured using an ambulatory blood pressure monitor.
|
12 weeks
|
Change from baseline Psychomotor Vigilance Task reaction time at 12 weeks
Time Frame: 12 weeks
|
3-minute Psychomotor Vigilance Tasks will be done to quantify the speed with which subjects respond to a visual stimulus.
|
12 weeks
|
Change from baseline Psychomotor Vigilance Task lapses per test at 12 weeks
Time Frame: 12 weeks
|
3-minute Psychomotor Vigilance Tasks will be done to quantify the speed with which subjects respond to a visual stimulus.
|
12 weeks
|
Change from baseline Functional Outcome of Sleep Questionnaire (FOSQ) at 12 weeks
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ali Azarbarzin, PhD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PhenOSA
- 1R01HL153874 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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