Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

This study is looking at how obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) together might affect thinking skills, sleepiness, and quality of life in elderly Veterans. Researchers want to see if having both conditions, called 'Overlap Syndrome,' makes these problems worse compared to having just one condition. They will also investigate if treatments like CPAP (continuous positive airway pressure) alone, or CPAP combined with NIPPV (non-invasive positive pressure ventilation) and/or oxygen, can improve these issues. You might be able to join if you are an elderly Veteran (ages 60-89) with moderate-to-severe OSA and moderate-to-severe COPD. The study aims to see if these treatments improve neurocognitive function, sleepiness, and quality of life after 3 months.

Study design
This is an interventional study planning to enroll 108 participants. It compares different treatment approaches for sleep apnea and COPD.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as neurocognitive function, sleepiness, and quality of life, will be measured at 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02703207

Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

Recruiting
NAAges 60–89InterventionalTreatment
VA Office of Research and Development
~108 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Positive airway pressureNIPPV and /or oxygen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurocognitive function
Measured over Change from baseline neurocognitive function at 3 months
+9 more outcomes measured
Obstructive Sleep Apnea
OSA COPD Overlap Syndrome
1 sites across 1 states
Michigan1
  • Susmita Chowdhuri, MD MS · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center, Detroit, MI

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Eligibility criteria

Inclusion

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

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
  • Neurocognitive functionChange from baseline neurocognitive function at 3 months

    The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  • SleepinessChange from baseline sleepiness at 3 months

    Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.

  • Quality of life (Short-Form survey)Change from baseline quality of life at 3 months

    Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.

  • Neurocognitive testChange from baseline at 3 months

    The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  • Neurocognitive test (Paced Auditory Serial Addition Test)Change from baseline at 3 months

    The neurocognitive test: Paced Auditory Serial Addition Test (PASAT) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.

  • Neurocognitive test (Stroop Color-Word Interference)Change from baseline at 3 months

    The neurocognitive test: Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  • Neurocognitive test (DIGIT test)Change from baseline at 3 months

    The neurocognitive DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  • Neurocognitive test (Wechsler Abbreviated Scale of Intelligence)Change from baseline at 3 months

    The neurocognitive test: abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  • Quality of life (Functional Outcomes of Sleep Questionnaire)Change from baseline quality of life at 3 months

    Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ)-10. There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.

  • Quality of life (St. George's Respiratory Questionnaire)Change from baseline quality of life at 3 months

    Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.