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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2025-09-08

No results posted yet for this study

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Susmita Chowdhuri, MD MS · John D. Dingell VA Medical Center, Detroit, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2026-03-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179981 on ClinicalTrials.gov