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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT04179981
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
668 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Neurocognitive function Trails A and Trails B [ Time Frame: Change from baseline at 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Ruchi Rastogi, MS
[email protected]
(313) 576-4464
Edi Levi, MD
[email protected]
(313) 576-4451
Susmita Chowdhuri, MD MS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
COPD
By specialty
PulmonologyLung disease
By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

Related Studies