RecruitingNot ApplicableNCT04179981

Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)


Sponsor

VA Office of Research and Development

Enrollment

668 participants

Start Date

Dec 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether treating sleep apnea with CPAP (a machine that keeps your airway open during sleep) improves health outcomes in older veterans who also have COPD (a chronic lung disease). **You may be eligible if...** - You are 60 years or older - You have moderate-to-severe sleep apnea (confirmed by a sleep study) AND moderate-to-severe COPD (confirmed by lung function tests) - You have a significant history of smoking (more than 10 pack-years) - You have not previously used CPAP or a dental device for sleep apnea **You may NOT be eligible if...** - You already use CPAP or a mouth appliance - You have central sleep apnea (a different type from obstructive sleep apnea) - You are currently on a ventilator - You have severe oxygen-dependent lung disease or end-stage heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPositive airway pressure

Positive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.

OTHERConservative care (control arm)

Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.


Locations(1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States

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NCT04179981


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