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NCT04179981 | RECRUITING | Sleep Apnea Syndrome

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

VA Office of Research and Development

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.

Condition or disease

Sleep Apnea Syndrome

Obstructive Sleep Apnea

COPD

Overlap Syndrome

Quality of Life

Neurocognitive Function

Sleepiness

Elderly

Positive Airway Pressure

Intervention/treatment

Positive airway pressure

Conservative care (control arm)

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 668 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Actual Study Start Date : 2020-12-01
Estimated Primary Completion Date : 2026-03-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)

Location Details

NCT04179981

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Locations

RECRUITING

United States, Road cancer

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Road cancer, United States, 48201-1916