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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    108
  • sponsor
    VA Office of Research and Development
Updated on 11 March 2022
polysomnography
sleep disorder
apnea-hypopnea index

Summary

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.

Description

OBJECTIVE: Describe the clinical and physiological characteristics of obstructive sleep apnea (OSA) and comorbid chronic obstructive pulmonary disease (COPD) and study the impact of treatment on neurocognitive outcomes in elderly Veterans.

RESEARCH PLAN: The investigators will study if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness with reduced quality of life compared to patients with either OSA or COPD alone (Aim 3) and whether treatment with PAP/NIPPV and supplemental oxygen compared to CPAP alone in elderly Veterans with moderate-to-severe OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness and quality of life (QoL).

Aim A: To determine if elderly Veterans with OSA and comorbid COPD have increased neurocognitive deficits and sleepiness compared to patients with either OSA or COPD.

Hypothesis: Elderly veterans (age 60 years) with moderate-to-severe OSA and concomitant moderate-to-severe COPD will have significantly increased cognitive deficits and daytime sleepiness compared with similar patients with OSA alone or COPD alone.

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.

Aim B. To determine if treatment with PAP/NIPPV and/or supplemental oxygen compared to CPAP alone in elderly Veterans with OSA and concomitant moderate-to-severe COPD will improve cognitive function, sleepiness, and QoL.

Hypothesis: Therapy with PAP and supplemental oxygen will reverse neurocognitive deficits in one or more domains, reduce sleepiness, and improve QoL compared with CPAP alone in patients with moderate-to-severe OSA and concomitant moderate COPD. This aim will evaluate which specific deficits in neurocognitive function in patients with moderate-to-severe Overlap Syndrome are reversible and most sensitive to the effects of positive airway pressure (PAP) and oxygen vs CPAP alone.

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.

Details
Condition Obstructive Sleep Apnea, OSA COPD Overlap Syndrome
Treatment Positive Airway Pressure, NIPPV and /or oxygen
Clinical Study IdentifierNCT02703207
SponsorVA Office of Research and Development
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

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
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