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

Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To study this aim the investigators will prospectively administer and compare the results of a battery of cognitive tests, and sleepiness and QoL questionnaires in elderly patients with OSA, COPD, and the Overlap Syndrome."
  • "To study this aim the investigators will randomize patients with the Overlap Syndrome to 3months of therapy with PAP and/or oxygen vs CPAP alone for 3 months and evaluate impact on neurocognitive function, sleepiness and quality of life before and after therapy."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether having both sleep apnea (breathing that stops during sleep) and COPD (a long-term lung disease) causes more thinking and memory problems than either condition alone in older Veterans. It also tests whether adding oxygen to air-pressure treatment improves thinking, memory, and quality of life more than air-pressure treatment alone.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age listed as 60 years; men and women may join.
  • Moderate-to-severe sleep apnea confirmed by an overnight sleep test.
  • Moderate-to-severe COPD confirmed by breathing tests within the past year, with a smoking history of 10 pack-years (such as one pack a day for 10 years).

Who can't join

  • Mild COPD, mild sleep apnea, or both; or central sleep apnea, with more than 5 pauses in breathing per hour caused by missing signals from the brain.
  • Already using daytime oxygen, nighttime air-pressure treatment, or a mouth device for sleep apnea; or unable to use a breathing mask or machine because of face injuries, vision problems, or trouble using the hands.
  • Current smoking, illegal drug use, more than 2 alcoholic drinks a day, or a history of heavy drinking; or pregnancy.
  • Shallow breathing caused by nerve, muscle, or chest wall disease; major trouble expanding the lungs on breathing tests; hospital admission for an acute illness in the past 4 months; or expected to live less than 6 months.
  • Unstable heart disease, worsening heart failure, heart pumping strength below 45%, or an uncontrolled uneven heartbeat.
  • A current mental health condition needing medicines that cause sleepiness. For study parts 3 and 4 only: medicines that may affect alertness or daily activities, or depression with a questionnaire score above 10.
  • A history of learning disability or inability to sign the consent form.
  • A sleepiness questionnaire score listed as 18, or a car crash or near-miss caused by sleepiness in the past 12 months.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (1)

MI