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

NCT02703207 | Recruiting DMC FDA Device

• 1 other identifier: E2227-P
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Neurocognitive function

  The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  Change from baseline neurocognitive function at 3 months

• Sleepiness

  Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.

  Change from baseline sleepiness at 3 months

• Quality of life (Short-Form survey)

  Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.

  Change from baseline quality of life at 3 months

• Neurocognitive test

  The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  Change from baseline at 3 months

• Neurocognitive test (Paced Auditory Serial Addition Test)

  The neurocognitive test: Paced Auditory Serial Addition Test (PASAT) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.

  Change from baseline at 3 months

• Neurocognitive test (Stroop Color-Word Interference)

  The neurocognitive test: Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  Change from baseline at 3 months

• Neurocognitive test (DIGIT test)

  The neurocognitive DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  Change from baseline at 3 months

• Neurocognitive test (Wechsler Abbreviated Scale of Intelligence)

  The neurocognitive test: abbreviated Wechsler Abbreviated Scale of Intelligence (WASI) will be administered to evaluate verbal comprehension and working memory. This score is adjusted for age. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.

  Change from baseline at 3 months

• Quality of life (Functional Outcomes of Sleep Questionnaire)

  Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ)-10. There are 5 subscale domains of the FOSQ (General Productivity, Social Outcome, Activity Level, Vigilance, and Intimate Relationships and Sexual Activity). There all range from 0-20, where a higher value is a better outcome. The total FOSQ is the sum of these subscale domains and ranges from 0-100, where a higher value is a better outcome.

  Change from baseline quality of life at 3 months

• Quality of life (St. George's Respiratory Questionnaire)

  Quality of Life (Qol) Questionnaires: Disease specific QoL will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ has three subscale domains (Symptoms, Activity, and Impacts), which range from 0-100, where a higher value indicates a worse outcome. The total SGRQ is the average of these subscale domains and is on a scale of 0-100, where a higher value is a worse outcome.

  Change from baseline quality of life at 3 months

Secondary Outcomes (5)

• Dyspnea

  Change from baseline at 3 months

• Hours of nightly positive airway pressure (PAP) use/NIPPV use

  90 days after start of therapy

• Hours of nightly oxygen use

  3 months after start of therapy

• Borg scale

  Change from baseline at 3 months

• Blood pressure

  At baseline

Study Arms (3)

Positive airway pressure therapy

ACTIVE COMPARATOR

Control group patients will receive standard care with PAP- positive airway pressure.

Device: Positive airway pressure; Device: NIPPV and /or oxygen

COPD

NO INTERVENTION

The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.

OSA and comorbid COPD

NO INTERVENTION

Eligible elderly (age \>/=60yrs) Veterans with moderate to severe Overlap Syndrome.

Interventions

Positive airway pressure DEVICE

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

Also known as: Standard of care control arm

Positive airway pressure therapy

NIPPV and /or oxygen DEVICE

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

Also known as: Active intervention

Positive airway pressure therapy

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleepiness

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Susmita Chowdhuri, MD MS

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruchi Rastogi, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 9, 2016
• Study Start: August 17, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)