Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea

NCT ID: NCT04575740

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2025-09-30

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").

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Positive Airway Pressure Device

All participants will receive PAP therapy

Group Type: EXPERIMENTAL

PAP

Intervention Type: DEVICE

Positive airway pressure to treat sleep apnea

Interventions

PAP

Positive airway pressure to treat sleep apnea

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ali Azarbarzin

Associate Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Azarbarzin, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01HL153874

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PhenOSA

Identifier Type: -

Identifier Source: org_study_id