Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

December 11, 2025 updated by: Ali Azarbarzin, Brigham and Women's Hospital

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Positive Airway Pressure Device
All participants will receive PAP therapy
Device: PAP
Positive airway pressure to treat sleep apnea

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Azarbarzin, PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PhenOSA
  • 1R01HL153874 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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