Positive Airway Pressure Treatment for Sleep Apnea and COPD

At a Glance

Age: 60 – 89
Sex: Any
Study type: Interventional
Purpose: Treatment
Participants needed: 108 (estimated)
Sponsor: VA Office of Research and Development · Federal

Who this trial is looking for

This trial is looking for older veterans with sleep apnea and chronic obstructive pulmonary disease (COPD). Participants will be studied to see how their conditions affect thinking and memory and whether treatment can improve these issues.

Are You a Good Fit for This Trial?

You may be able to join if

I have been diagnosed with obstructive sleep apnea
I have been diagnosed with moderate-to-severe COPD
I am at least 60 years old
I am male or female

You may not be able to join if

I have mild COPD
I have mild obstructive sleep apnea
I smoke currently
I am pregnant
I have unstable heart disease
I have a recent serious illness within the last 4 months
I cannot use a nasal or face mask
I have a life expectancy of less than 6 months

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About This Trial

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. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Ve…

Trial Locations

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Eligibility Criteria

Inclusion 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 c…

Inclusion 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 \<70% and FEV1 \>30% and \<80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking * Age 60 years * Male or female gender Exclusion Criteria: * 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

Contacts

Ruchi Rastogi, MS

(313) 576-4464

ruchi.rastogi@va.gov

CONTACT

Positive Airway Pressure Treatment for Sleep Apnea and COPD

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