Clinical trial NCT02703207: Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Official title: Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
OSA COPD Overlap Syndrome
Keywords: obstructive sleep apnea
COPD
Overlap syndrome
quality of life
neurocognitive function
sleepiness
elderly
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-03-09
Enrollment: 108
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Neurocognitive function
timeFrame: Change from baseline neurocognitive function at 3 months
measure: Sleepiness
timeFrame: Change from baseline sleepiness at 3 months
measure: Quality of life
timeFrame: Change from baseline quality of life at 3 months
measure: Neurocognitive test
timeFrame: Change from baseline at 3 months
measure: Neurocognitive test
timeFrame: Change from baseline at 3 months
measure: Neurocognitive test
timeFrame: Change from baseline at 3 months
measure: Neurocognitive test
timeFrame: Change from baseline at 3 months
measure: Neurocognitive test
timeFrame: Change from baseline at 3 months
measure: Quality of life
timeFrame: Change from baseline quality of life at 3 months
measure: Quality of life
timeFrame: Change from baseline quality of life at 3 months
Secondary outcomes:
measure: Dyspnea
timeFrame: Change from baseline at 3 months
measure: Hours of nightly positive airway pressure (PAP) use/NIPPV use
timeFrame: 90 days after start of therapy
measure: Hours of nightly oxygen use
timeFrame: 3 months after start of therapy
measure: Borg scale
timeFrame: Change from baseline at 3 months
measure: Blood pressure
timeFrame: At baseline
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: John D. Dingell VA Medical Center, Detroit, MI
name: Susmita Chowdhuri, MD MS
role: PRINCIPAL_INVESTIGATOR
References: