Clinical trial NCT04179981: Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea Syndrome
Obstructive Sleep Apnea
COPD
Overlap Syndrome
Quality of Life
Neurocognitive Function
Sleepiness
Elderly
Positive Airway Pressure
Keywords: Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
positive airway pressure
cognitive function
quality of life
sleepiness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-11-27
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing outcomes in patients with OVS after randomization to PAP therapy vs. conservative care in a parallel group fashion
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Neurocognitive function Trails A and Trails B
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function PASAT
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function Stroop color-word interference
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function DIGIT
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function WASI
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function WMS
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function PVT
timeFrame: Change from baseline at 3 and 6 months
measure: Neurocognitive function HVLT-R
timeFrame: Change from baseline at 3 and 6 months
measure: Sleepiness ESS
timeFrame: Change from baseline at 3 and 6 months
measure: Sleep quality PSQI
timeFrame: Change from baseline at 3 and 6 months
measure: Quality of life SF-36v2
timeFrame: Change from baseline at 3 and 6 months
measure: Quality of life FOSQ
timeFrame: Change from baseline at 3 and 6 months
measure: Quality of life SGRQ
timeFrame: Change from baseline at 3 and 6 months
Secondary outcomes:
measure: Hours of nightly positive airway pressure (PAP) use
timeFrame: Change from baseline at 3 and 6 months
measure: Patient preferance for type of PAP (PAP arm)
timeFrame: at 3 and 6 months
measure: Fatigue severity
timeFrame: Change from baseline at 3 and 6 months
measure: Sleep-dependent memory
timeFrame: At baseline and at 3 months
measure: Blood CO2 or bicarbonate level
timeFrame: At baseline and at 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center, Detroit, MI
state: Michigan
Study officials:
affiliation: John D. Dingell VA Medical Center, Detroit, MI
name: Susmita Chowdhuri, MD MS
role: PRINCIPAL_INVESTIGATOR
References: