Recruiting

Positive Airway Pressure

Sponsor:

VA Office of Research and Development

Code:

NCT04179981

Conditions

Sleep Apnea Syndrome

Obstructive Sleep Apnea

COPD

Overlap Syndrome

Quality of Life

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Positive airway pressure

Conservative care (control arm)

Study Details

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

Study ID

NCT04179981

Start date

Dec 1, 2020

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients who cannot give informed consent
  • Patients receiving hospice care
  • Pregnant women due to unknown risks

Study Design

Enrollment

668 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Conservative care (control arm)

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.

active comparator: PAP therapy arm

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

Interventions

Positive airway pressure

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.

Conservative care (control arm)

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.

Primary outcome measure

  • Neurocognitive function Trails A and Trails B [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function PASAT [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function Stroop color-word interference [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function DIGIT [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function WASI [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function WMS [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function PVT [ Time Frame: Change from baseline at 3 and 6 months ]
  • Neurocognitive function HVLT-R [ Time Frame: Change from baseline at 3 and 6 months ]
  • Sleepiness ESS [ Time Frame: Change from baseline at 3 and 6 months ]
  • Sleep quality PSQI [ Time Frame: Change from baseline at 3 and 6 months ]
  • Quality of life SF-36v2 [ Time Frame: Change from baseline at 3 and 6 months ]
  • Quality of life FOSQ [ Time Frame: Change from baseline at 3 and 6 months ]
  • Quality of life SGRQ [ Time Frame: Change from baseline at 3 and 6 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

Ruchi Rastogi, MS

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

Edi Levi, MD

(313) 576-4451edi.levi@va.gov

Principal Investigator:

Susmita Chowdhuri, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-05.