Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Ob… (NCT04179981) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
United States668 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cognit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurocognitive function Trails A and Trails B
Timeframe: Change from baseline at 3 and 6 months
2
Neurocognitive function PASAT
Timeframe: Change from baseline at 3 and 6 months
3
Neurocognitive function Stroop color-word interference