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New treatment option for Obstructive Sleep Apnea
Official title Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
ClinicalTrials.gov ID: NCT02703207
What this study is testing
- What it's testing
- Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 89
You may be able to join if
- OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index...
- Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio \ 30% and \<80% of predicted based...
- Age 60 years
- Male or female gender
You likely can't join if
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- Central sleep apnea defined as central apnea index \>5 per hour
- Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
- Current smokers
See the full eligibility criteria
- OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15\ per hour by polysomnography
- Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio \ 30% and \<80% of predicted based on PFT done within the past 1 year and a past significant history (10...
- Age 60 years
- Male or female gender
- Mild COPD
- Mild OSA
- Overlap Syndrome with mild OSA plus mild COPD
- Central sleep apnea defined as central apnea index \>5 per hour
- Already on daytime oxygen or nighttime CPAP, NIPPV, oral appliance
- Current smokers
- Pregnant women
- Disorders of hypoventilation due to known neuromuscular or chest wall diseases\ \
- Patients with significant restrictive lung disease on pulmonary function testing
- Recent admission for any acute illness within the prior 4 months
- Current psychiatric illness requiring sedating medications
- Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
- For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score \>10)
- History of learning disability
- Inability to sign consent
- Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
- Patients with unstable heart disease, decompensated heart failure, ejection fraction\<45% or uncontrolled arrhythmias
- Patients unable to use either a nasal or face mask (e.g., facial trauma)
- Consumption of \> 2 alcoholic beverages per day or past history of excessive alcohol use
- Current use of illicit drugs
- Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
- Life expectancy is less than 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 89 years. 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.