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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
John D. Dingell VA Medical Center, Detroit, MI
RECRUITING
Detroit
Contact Information
Primary
Ruchi Rastogi, MS
ruchi.rastogi@va.gov
(313) 576-4464
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 668
Treatments
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.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov