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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

neurodegenerative disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Positive airway pressure

    Device

    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.

  • Conservative care (control arm)

    Other intervention

    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.

Treatment groups

668 Participants
are divided into 2 treatment groups
Group A: Conservative care (control arm)Other 1 intervention
Group B: PAP therapy armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neurocognitive function Trails A and Trails B

Trails A and 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 and 6 months
2

Neurocognitive function PASAT

PASAT (Paced Auditory Serial Addition Test) will be administered to evaluate vigilance and executive function. The PASAT is recorded as the total number of correct responses (from 0-60), or the percent of correct responses out of 60 (from 0-100), where a higher value is a better outcome.

Time frame
Change from baseline at 3 and 6 months
3

Neurocognitive function Stroop color-word interference

Stroop color-word interference test will be administered to evaluate executive function. This score is adjusted for age, 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 and 6 months
4

Neurocognitive function DIGIT

DIGIT test will be administered to evaluate short-term and working memory. This score is adjusted for age. 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 and 6 months

Secondary outcomes

1

Hours of nightly positive airway pressure (PAP) use

Collection of PAP adherence data from the smart card of the PAP machine or from online data.

Time frame
Change from baseline at 3 and 6 months
2

Patient preferance for type of PAP (PAP arm)

A visual analog scale to determine preference to CPAP vs NIPPV therapy. A scores will range from -10 to +10, where a higher score is better.

Time frame
at 3 and 6 months
3

Fatigue severity

Fatigue Severity Scale (FSS): FSS measures how fatigue affects motivation, exercise, physical functioning, carrying out duties, interfering with work, family, or social life. Where a higher value is a worse outcome.

Time frame
Change from baseline at 3 and 6 months
4

Sleep-dependent memory

In a subgroup of patients, the investigators will perform Word-pair test and PVT before and after sleep period, this is an exploratory measure.

Time frame
At baseline and at 3 months

Other outcomes

Sponsors and contacts

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