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Tests breathing machines and oxygen in older Veterans with sleep apnea and COPD

Tests airway pressure with or without oxygen in older Veterans with sleep apnea and COPD.

Key facts

Who runs it
VA Office of Research and Development
Where
Detroit, United StatesSee the site
Trial code
Registry title
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Status
Recruiting
People taking part
108 people, planned
Started
17 Aug 2016
Expected to end
31 Mar 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Positive airway pressure
  • NIPPV and /or oxygen
Record updated
26 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for older Veterans with moderate-to-severe sleep apnea and moderate-to-severe COPD, to study thinking skills and the effect of treatment.

Age
60 to 89 years
Sex
Men and women can join.
Disease stage
Moderate-to-severe obstructive sleep apnea (apnea hypopnea index of 15 or more per hour on a sleep study) and moderate-to-severe COPD (GOLD 2 and 3, FEV1 above 30% and below 80% of predicted).
Earlier treatment
People already on daytime oxygen, or on nighttime CPAP, NIPPV or an oral appliance, cannot join.
Biomarker or test result
FEV1/FVC ratio below 70% on a lung function test done within the past year, and a past smoking history of 10 pack-years.

Main reasons for not taking part

  • Current smokers
  • Mild COPD or mild sleep apnea
  • Central sleep apnea (central apnea index above 5 per hour)
  • Unstable heart disease, decompensated heart failure, ejection fraction below 45% or uncontrolled arrhythmias
  • Admission for an acute illness within the past 4 months

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Recent admission for any acute illness within the prior 4 months
  • Use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning for Aim 3/4
  • Epworth sleepiness score 18 or a near-miss or prior automobile accident due to sleepiness within the past 12 months
  • Current use of illicit drugs
  • Overlap Syndrome with mild OSA plus mild COPD
  • Disorders of hypoventilation due to known neuromuscular or chest wall diseases**
  • Patients with significant restrictive lung disease on pulmonary function testing
  • Current psychiatric illness requiring sedating medications
  • History of learning disability
  • Consumption of > 2 alcoholic beverages per day or past history of excessive alcohol use
  • Patients with unstable heart disease, decompensated heart failure, ejection fraction<45% or uncontrolled arrhythmias
  • Mild COPD
  • Mild OSA
  • 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
  • For Aim 3 and 4 only, existing depression as assessed by the PHQ (Patient Health Questionnaire)-9 (score >10)
  • Inability to sign consent
  • Patients unable to use either a nasal or face mask (e.g., facial trauma)
  • Patients who have problems with vision or dexterity and hence, cannot use CPAP/NIPPV
  • Life expectancy is less than 6 months

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 60 and 89 years old?

Where in United States

  • John D. Dingell VA Medical Center, Detroit, MIDetroit, United StatesContact: Lynn M HuberTaking people

About the trial

What the trial wants to find out

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 Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.

The 3 groups in the trial

  • Positive airway pressure therapyExisting treatment, for comparison

    Control group patients will receive standard care with PAP- positive airway pressure.

    Treatment: Positive airway pressure and NIPPV and /or oxygen

  • COPDNo study treatment, for comparison

    The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.

  • OSA and comorbid COPDNo study treatment, for comparison

    Eligible elderly (age \>/=60yrs) Veterans with moderate to severe Overlap Syndrome.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Plain-language title
Tests breathing machines and oxygen in older Veterans with sleep apnea and COPDGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT02703207, who can take part
Record updated
26 May 2026