Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 60 - 89 |
| Updated: | 1/12/2019 |
| Start Date: | August 17, 2016 |
| End Date: | December 31, 2019 |
| Contact: | Ruchi Rastogi, MSc |
| Email: | rrastogi@med.wayne.edu |
| Phone: | (313) 576-1000 |
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.
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.
(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
We found this trial at
1
site
Detroit, Michigan 48201
Principal Investigator: Susmita Chowdhuri, MD
Phone: 313-576-1000
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