Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT02703207

Conditions

Obstructive Sleep Apnea

OSA COPD Overlap Syndrome

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Positive airway pressure

NIPPV and /or oxygen

Study Details

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.

Conditions

Obstructive Sleep Apnea

OSA COPD Overlap Syndrome

Study ID

NCT02703207

Start date

Aug 17, 2016

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Positive airway pressure

CPAP will be applied as standard of care for diagnosis of moderate to severe OSA

NIPPV and /or oxygen

supplemental oxygen will be applied to PAP/non-invasive positive pressure therapy

Primary outcome measure

  • Neurocognitive function [ Time Frame: Change from baseline neurocognitive function at 3 months ]
  • Sleepiness [ Time Frame: Change from baseline sleepiness at 3 months ]
  • Quality of life (Short-Form survey) [ Time Frame: Change from baseline quality of life at 3 months ]
  • Neurocognitive test [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive test (Paced Auditory Serial Addition Test) [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive test (Stroop Color-Word Interference) [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive test (DIGIT test) [ Time Frame: Change from baseline at 3 months ]
  • Neurocognitive test (Wechsler Abbreviated Scale of Intelligence) [ Time Frame: Change from baseline at 3 months ]
  • Quality of life (Functional Outcomes of Sleep Questionnaire) [ Time Frame: Change from baseline quality of life at 3 months ]
  • Quality of life (St. George's Respiratory Questionnaire) [ Time Frame: Change from baseline quality of life at 3 months ]

Central Contacts and Locations

Central contacts

Ruchi Rastogi, MS

(313) 576-4464ruchi.rastogi@va.gov

Locations

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Lynn M Huber

313-576-3106lynn.huber@va.gov

Principal Investigator:

Susmita Chowdhuri, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • obstructive sleep apnea
  • COPD
  • Overlap syndrome
  • quality of life
  • neurocognitive function
  • sleepiness
  • elderly

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-05-26.