Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-89
SponsorVA Office of Research and Development
About this trial
Cognitive dysfunction in the aging Veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases, that often co-exist as the 'Overlap Syndrome', combine to enhance cognitive impairment in the elderly Veteran population. Thus, the investigators will study whether elderly patients with Overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with positive airway pressure (PAP) and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly Veterans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
OSA defined by the International classification of Sleep Disorders-322 diagnostic criteria with moderate-to-severe disease, i.e. apnea hypopnea index (AHI) 15* per hour by polysomnography
Moderate-to-severe COPD defined by GOLD 2 and 3 (Global Obstructive Lung Disease) 23 criteria with FEV1/FVC ratio <70% and FEV1 >30% and <80% of predicted based on PFT done within the past 1 year and a past significant history (10 pack-years) of smoking
Age 60 years
Male or female gender
Disqualifiers
Mild COPD
Mild OSA
Overlap Syndrome with mild OSA plus mild COPD
Central sleep apnea defined as central apnea index >5 per hour
Trial design
Design model
Parallel
Treatments tested in this trial
Positive airway pressure
DeviceCPAP will be applied as standard of care for diagnosis of moderate to severe OSA
NIPPV and /or oxygen
Devicesupplemental oxygen will be applied to PAP/non-invasive positive pressure therapy
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Positive airway pressure therapyActive comparator 2 interventions
Group B: COPDNo intervention 0 interventions
Group C: OSA and comorbid COPDNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Neurocognitive function
The neurocognitive test - Trails A test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Time frame
Change from baseline neurocognitive function at 3 months2
Sleepiness
Epworth Sleepiness Scale (ESS) score will be measured. This score is on a scale of 0-24, where a higher value indicates a worse outcome.
Time frame
Change from baseline sleepiness at 3 months3
Quality of life (Short-Form survey)
Quality of Life (Qol) Questionnaires: QoL will be assessed using the Short-Form survey (SF-12). There are two subscale domain scores (Physical Health Composite Score-PCS and Mental Health Composite Score-MCS). These are on a scale of 0-100, where higher values indicate a better outcome.
Time frame
Change from baseline quality of life at 3 months4
Neurocognitive test
The neurocognitive test - Trails B test will be administered to evaluate attention and psychomotor function. This score is adjusted for age, race, gender, and years of education. Scored on a Standard scale of 100 +/- 15 for normal ranges, above 115 is above average, below 85 is considered below average.
Time frame
Change from baseline at 3 monthsSecondary outcomes
1
Dyspnea
6 minute walk test (6MWT): Participants are instructed to achieve maximal distance. There is no scale, but a larger value is a better outcome.
Time frame
Change from baseline at 3 months2
Hours of nightly positive airway pressure (PAP) use/NIPPV use
Collection of PAP adherence data from the smart card of the PAP machine or from online data.
Time frame
90 days after start of therapy3
Hours of nightly oxygen use
Adherence to supplemental oxygen (O2) will be determined by the total hours of nightly O2 use obtained from the O2 concentrator that is provided by the vendor.
Time frame
3 months after start of therapy4
Borg scale
This measures the level of dyspnea during the 6 minute walk test. It is on a scale of 0-10, where a larger value is a worse outcome.
Time frame
Change from baseline at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov