Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

NCT04179981 | Recruiting DMC FDA Device

• 1 other identifier: E3124-R
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD) are highly prevalent chronic respiratory diseases in the Veteran population. OSA co-occurring with COPD, known as Overlap Syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in Veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.

Conditions

Sleep Apnea Syndrome; Obstructive Sleep Apnea; COPD; Overlap Syndrome; Quality of Life; Neurocognitive Function; Sleepiness; Elderly; Positive Airway Pressure

Keywords

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; positive airway pressure; cognitive function; quality of life; sleepiness

Outcome Measures

Primary Outcomes (13)

• Neurocognitive function Trails A and Trails B

  Trails A and 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 and 6 months

• Neurocognitive function PASAT

  PASAT (Paced Auditory Serial Addition Test) 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 and 6 months

• Neurocognitive function Stroop color-word interference

  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 and 6 months

• Neurocognitive function DIGIT

  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 and 6 months

• Neurocognitive function WASI

  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 and 6 months

• Neurocognitive function WMS

  Wechsler Memory test (WMS) will be administered to measure Verbal comprehension, and working and visual memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  Change from baseline at 3 and 6 months

• Neurocognitive function PVT

  Psychomotor Vigilance Test (PVT) will be administered to measure Alertness and vigilance, in terms of number of lapses and reaction time. The performance score ranges from 0-100, where a higher value is a better outcome.

  Change from baseline at 3 and 6 months

• Neurocognitive function HVLT-R

  Hopkins Verbal Learning Test - Revised (HVLT-R) will be administered to evaluate Verbal learning and memory. Scored on a Standard scale of 100 +/- 15, where a higher score is a better outcome.

  Change from baseline at 3 and 6 months

• Sleepiness ESS

  Epworth sleepiness scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates greater degree of sleepiness.

  Change from baseline at 3 and 6 months

• Sleep quality PSQI

  Pittsburgh Sleep Quality Index (PSQI) is a detailed assessment of subject sleep quality over the most recent month by considering seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score to assess sleep quality on a scale of "poor" to "good".

  Change from baseline at 3 and 6 months

• Quality of life SF-36v2

  QoL will be assessed using the survey SF-36v2 Health survey. Thirty-five of the SF-36v2 items are used to measure eight domains of health-related quality of life. These are on a scale of 0-100, where higher values indicate a better outcome.

  Change from baseline at 3 and 6 months

• Quality of life FOSQ

  Disease specific QoL will be assessed using the Functional Outcomes of Sleep Questionnaire FOSQ/(FOSQ). 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 at 3 and 6 months

• Quality of life SGRQ

  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 at 3 and 6 months

Secondary Outcomes (5)

• Hours of nightly positive airway pressure (PAP) use

  Change from baseline at 3 and 6 months

• Patient preferance for type of PAP (PAP arm)

  at 3 and 6 months

• Fatigue severity

  Change from baseline at 3 and 6 months

• Sleep-dependent memory

  At baseline and at 3 months

• Blood CO2 or bicarbonate level

  At baseline and at 6 months

Study Arms (2)

Conservative care (control arm)

OTHER

Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.

Other: Conservative care (control arm)

PAP therapy arm

ACTIVE COMPARATOR

PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.

Device: Positive airway pressure

Interventions

Positive airway pressure DEVICE

Positive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.

PAP therapy arm

Conservative care (control arm) OTHER

Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.

Conservative care (control arm)

Eligibility Criteria

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

You may qualify if:

• OSA with moderate-to-severe disease, AHI 20 per hour by in-lab polysomnography with concomitant moderate-severe COPD based on pulmonary function tests (PFTS) and with past significant history (\>10 pack-years) of smoking
• Male or female gender
• Age greater than or equal to 60 years
• Stable treatment regimen for COPD

You may not qualify if:

• Current or prior treatment with PAP or oral appliance
• Central sleep apnea defined as central apnea index \>5 per hour and comprising 50% of AHI
• Known primary neuromuscular diseases
• Disorders that may impact cognitive function including:
• neurodegenerative disorders
• traumatic brain injury
• untreated PTSD and/or history of learning disability
• Medicines that may cause or alter sleepiness: sedative hypnotics, or stimulants as these may alter the results
• Patient is actively suicidal due to depression, unstable mental health condition
• Epworth sleepiness score \>16 (severe sleepiness) or a near-miss or prior automobile accident due to sleepiness within the past 12 months
• Narcolepsy is the primary sleep disorder, with requirement of stimulant medications
• Employed as a commercial driver or operating heavy machinery
• On long-term oxygen therapy prior to start of study, more than 12 hr/day
• Patients is unable to use either a nasal or face mask (e.g., facial trauma, claustrophobia)
• Consumption of \>3 alcoholic beverages per day or current use of some illicit drugs, as these may contribute to cognitive deficits

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 Syndromes; Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive; Sleepiness; Apnea; Nervous System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Comparing outcomes in patients with OVS after randomization to PAP therapy vs. conservative care in a parallel group fashion

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: December 1, 2020
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)