CPAP Therapy for Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen by Ali Azarbarzin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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").

Eligibility Criteria

Adults aged 21-80 with moderate to severe obstructive sleep apnea (OSA) and an apnea-hypopnea index over 15 events/hr are eligible. They must not be currently treated for OSA, have uncontrolled medical issues, heart failure, renal insufficiency, neurological conditions affecting respiration, or use respiratory-depressing meds. Pregnant women and those with other sleep disorders or active non-prescription opioid use are excluded.

Inclusion Criteria

I have been diagnosed with moderate to severe obstructive sleep apnea.

I am between 21 and 80 years old.

You have more than 15 pauses in breathing while sleeping.

Exclusion Criteria

I am currently taking medications that can slow my breathing.

I have a sleep or breathing disorder other than obstructive sleep apnea.

I have a history of heart failure, kidney issues, or neurological conditions affecting my breathing.

Participant Groups

The trial is testing the effectiveness of Continuous Positive Airway Pressure (CPAP) in treating OSA by using new metrics to assess hypoxemia ('hypoxic burden'), autonomic response ('heart rate burden'), and sleep fragmentation ('arousal burden') rather than just the apnea-hypopnea index.

Group I: Positive Airway Pressure Device Experimental Treatment 1 Intervention

All participants will receive PAP therapy

PAP is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Sleep-disordered breathing

🇺🇸 Approved in United States as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Sleep-disordered breathing

🇨🇦 Approved in Canada as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Sleep-disordered breathing

🇯🇵 Approved in Japan as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Sleep-disordered breathing

🇦🇺 Approved in Australia as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Sleep-disordered breathing

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Who Is Running the Clinical Trial?

Brigham and Women's Hospital Lead Sponsor

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

References