Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obstructive Sleep Apnea
- OSA COPD Overlap Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 89 years
- Gender
- Both males and females
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 Veter...
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.
Tracking Information
- NCT #
- NCT02703207
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Susmita Chowdhuri, MD John D. Dingell VA Medical Center, Detroit, MI