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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT02703207
Status
Recruiting
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Conditions

  • OSA COPD Overlap Syndrome
  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
60 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Positive airway pressure — DEVICE
    CPAP will be applied as standard of care for diagnosis of moderate to severe OSA
  • NIPPV and /or oxygen — DEVICE
    supplemental oxygen will be applied to PAP/non-invasive positive pressure therapy

Study Details

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.

Key Dates

Start date
Aug 17, 2016
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Positive airway pressure therapy
    Control group patients will receive standard care with PAP- positive airway pressure.
  • No Intervention: COPD
    The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.
  • No Intervention: OSA and comorbid COPD
    Eligible elderly (age \>/=60yrs) Veterans with moderate to severe Overlap Syndrome.

Primary Outcome Measure

Neurocognitive function [ Time Frame: Change from baseline neurocognitive function at 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Lynn M Huber
[email protected]
313-576-3106
Susmita Chowdhuri, MD MS (PRINCIPAL_INVESTIGATOR)

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By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

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