Effects of Positive Airway Pressure Therapy on Older Veterans with COPD and Sleep Apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of positive airway pressure (PAP) therapy on clinical outcomes in older veterans suffering from Overlap Syndrome, which combines chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The research aims to determine whether PAP therapy can improve sleep quality, reduce daytime sleepiness, and enhance cognitive function compared to conservative care. The study will also compare the effectiveness of continuous positive airway pressure (CPAP) and noninvasive positive airway pressure ventilation (NIPPV) in achieving these outcomes. By focusing on this specific veteran population, the study seeks to address a significant gap in existing research regarding the management of OSA and COPD together.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\>10 pack-years) of smoking
* Male or female gender
* Age greater than or equal to 60 years
* Stable treatment regimen for COPD

Exclusion Criteria:

* Current or prior treatment with PAP or oral appliance
* Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI
* Known primary neuromuscular diseases
* Disorders that may impact cognitive function including:

  * neurodegenerative disorders
  * traumatic brain injury
* untreated PTSD and/or history of learning disability
* Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results
* Patient is actively suicidal due to depression, unstable mental health condition
* Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months
* Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
* Employed as a commercial driver or operating heavy machinery
* On long-term oxygen therapy prior to start of study, more than 12 hr/day
* Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)
* Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits
* Patients who cannot give informed consent
* Patients receiving hospice care
* Pregnant women due to unknown risks

Where it's running

• John D. Dingell VA Medical Center, Detroit, MI
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Susmita Chowdhuri, MD MS — John D. Dingell VA Medical Center, Detroit, MI
• Study coordinator: Ruchi Rastogi, MS
• Email: ruchi.rastogi@va.gov
• Phone: (313) 576-4464

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.