NCT04179981 Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
| NCT ID | NCT04179981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Sleep Apnea Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 668 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 668 participants in total. It began in 2020-12-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Susmita Chowdhuri, MD MS
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center, Detroit, MI
Frequently Asked Questions
Who can join the NCT04179981 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Sleep Apnea Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04179981 currently recruiting?
Yes, NCT04179981 is actively recruiting participants. Contact the research team at ruchi.rastogi@va.gov for enrollment information.
Where is the NCT04179981 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT04179981 clinical trial?
NCT04179981 is sponsored by VA Office of Research and Development. The principal investigator is Susmita Chowdhuri, MD MS at John D. Dingell VA Medical Center, Detroit, MI. The trial plans to enroll 668 participants.