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New treatment option for Sleep Apnea Syndrome
Official title Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
ClinicalTrials.gov ID: NCT04179981
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function...
- Male or female gender
- Age greater than or equal to 60 years
- Stable treatment regimen for COPD
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.