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
  • End date
    Dec 31, 2025
  • participants needed
    250
  • sponsor
    VA Office of Research and Development
Updated on 24 March 2022
COPD
treatment regimen
chronic obstructive pulmonary disease
polysomnography
obstructive sleep apnea

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.

Description

There are no studies regarding the impact of PAP therapy on sleep disturbance, cognitive function and quality of life in patients with OVS. The investigators' rationale is that in patients with moderate-severe OVS, PAP therapy will effectively alleviate sleepiness, sleep disturbances and cognitive deficits, and, thereby, improve QoL. 'PAP' includes either continuous positive airway pressure (CPAP) or noninvasive positive airway pressure ventilation (NIPPV).

Objectives

Specifically, the investigators will study the effectiveness of PAP therapy vs. conservative care in reducing daytime sleepiness and in improving sleep quality and QoL in older Veterans with OVS.

The investigators will also explore whether CPAP is non-inferior to noninvasive positive airway pressure ventilation (NIPPV) in reducing daytime sleepiness, sleep disturbances and neurocognitive dysfunction, and in improving QoL in older Veterans with OVS.

Details
Condition Sleep Apnea Syndrome, Obstructive Sleep Apnea, COPD, Overlap Syndrome, Quality of Life, Neurocognitive Function, Sleepiness, Elderly, Positive Airway Pressure
Treatment Positive Airway Pressure, Conservative care (control arm)
Clinical Study IdentifierNCT04179981
SponsorVA Office of Research and Development
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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