Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive airway pressure, Conservative care (control arm).
- Who it may be relevant to
- Registry conditions: Sleep Apnea Syndrome, Obstructive Sleep Apnea, COPD, Overlap Syndrome. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Positive airway pressure
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. - 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.
Primary outcome measures
- Neurocognitive function Trails A and Trails B [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function PASAT [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function Stroop color-word interference [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function DIGIT [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function WASI [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function WMS [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function PVT [Time frame: Change from baseline at 3 and 6 months]
- Neurocognitive function HVLT-R [Time frame: Change from baseline at 3 and 6 months]
- Sleepiness ESS [Time frame: Change from baseline at 3 and 6 months]
- Sleep quality PSQI [Time frame: Change from baseline at 3 and 6 months]
Secondary outcome measures (5)
- Hours of nightly positive airway pressure (PAP) use [Time frame: Change from baseline at 3 and 6 months]
- Patient preferance for type of PAP (PAP arm) [Time frame: at 3 and 6 months]
- Fatigue severity [Time frame: Change from baseline at 3 and 6 months]
- Sleep-dependent memory [Time frame: At baseline and at 3 months]
- Blood CO2 or bicarbonate level [Time frame: At baseline and at 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- John D. Dingell VA Medical Center, Detroit, MI — Detroit
Identifiers
NCT: NCT04179981 · E3124-R