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