Trial Summary
What is the purpose of 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.
Is NIPPV a promising treatment for sleep apnea in people with COPD?Yes, NIPPV is a promising treatment for sleep apnea in people with COPD. It helps improve breathing by providing air pressure support, especially at night, which can be beneficial for those with breathing difficulties.124810
What safety data exists for sleep apnea treatments in COPD patients?The safety data for treatments like Non-Invasive Positive Pressure Ventilation (NIPPV) and related therapies in COPD patients is mixed. While NIPPV is effective in managing acute exacerbations and hypercapnic respiratory failure, its long-term benefits and safety in stable COPD patients remain controversial. Some studies suggest potential benefits, but results are conflicting, and more research is needed to establish clear safety and efficacy.12457
What data supports the idea that Sleep Apnea Treatments for Sleep Apnea with COPD is an effective treatment?The available research shows that Positive Airway Pressure (PAP) therapy is highly effective for treating sleep apnea, as it can significantly reduce the severity of the condition and improve quality of life. While the study on tele-assistance for COPD patients using oxygen therapy and non-invasive ventilation (NIV) does not directly address sleep apnea, it suggests that adding NIV to oxygen therapy can be beneficial. This implies that similar treatments, like PAP, could be effective for sleep apnea with COPD. In contrast, positional therapy for sleep apnea lacks strong evidence of effectiveness, making PAP a more reliable option.3691112
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you use hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect alertness or daytime functioning.
Eligibility Criteria
This trial is for elderly veterans aged 60 or older with moderate-to-severe obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD). Participants must have a significant history of smoking but cannot be current smokers, not on oxygen or CPAP therapy, and without central sleep apnea, recent acute illness, psychiatric illnesses requiring sedation, unstable heart conditions, or life expectancy under six months.Inclusion Criteria
I am 60 years old or older.
I have moderate-to-severe COPD, a history of significant smoking, and recent lung function tests.
I have moderate-to-severe sleep apnea with an AHI of 15 or more.
Exclusion Criteria
I am taking medication for a psychiatric condition that makes me sleepy.
I am unable to give consent by myself.
I do not have severe heart problems like uncontrolled irregular heartbeats or very weak heart pumping.
I have not been admitted to the hospital for a sudden illness in the last 4 months.
I have breathing issues due to muscle or chest wall diseases.
I have severe lung disease confirmed by tests.
Treatment Details
The study aims to see if positive airway pressure (PAP) treatments alone or combined with supplemental oxygen can improve cognitive function and quality of life in elderly veterans with 'Overlap Syndrome'—a combination of OSA and COPD. The effectiveness will be compared between those receiving just PAP versus PAP plus additional oxygen.
3Treatment groups
Active Control
Group I: Positive airway pressure therapyActive Control2 Interventions
Control group patients will receive standard care with PAP- positive airway pressure.
Group II: COPDActive Control1 Intervention
The COPD control group will be patients with moderate-to-severe COPD alone per the GOLD criteria.
Group III: OSA and comorbid COPDActive Control1 Intervention
Eligible elderly (age \>/=60yrs) Veterans with moderate to severe Overlap Syndrome.
NIPPV and /or oxygen is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as NIPPV and/or Oxygen for:
- Obstructive Sleep Apnea (OSA)
- Chronic Obstructive Pulmonary Disease (COPD)
- Overlap Syndrome
🇪🇺 Approved in European Union as NIPPV and/or Oxygen for:
- Obstructive Sleep Apnea (OSA)
- Chronic Obstructive Pulmonary Disease (COPD)
- Respiratory Failure
🇨🇦 Approved in Canada as NIPPV and/or Oxygen for:
- Obstructive Sleep Apnea (OSA)
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Respiratory Distress
Find a clinic near you
Research locations nearbySelect from list below to view details:
John D. Dingell VA Medical Center, Detroit, MIDetroit, MI
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
Domiciliary nocturnal intermittent positive pressure ventilation in patients with respiratory failure due to severe COPD: long-term follow up and effect on survival. [2022]There is increasing interest in the use of non-invasive nocturnal intermittent positive pressure ventilation (NIPPV) in the management of patients with chronic hypercapnoeic (type II) respiratory failure. Although this treatment enables patients requiring mechanical ventilatory support to the treated more readily at home, few studies have been done to demonstrate its long term benefits in chronic obstructive pulmonary disease (COPD) and the application of NIPPV in these circumstances remains controversial.
Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. [2018]Nocturnal non-invasive positive pressure ventilation (NIPPV) might be beneficial in stable hypercapnic patients with chronic obstructive pulmonary disease (COPD). However, evidence remains equivocal as conflicting results have been published.
Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. [2021]It is not known if proportional assist ventilation with load-adjustable gain factors (PAV+) may be used as a mode of support in critically ill patients. The aim of this study was to examine the effectiveness of sustained use of PAV+ in critically ill patients and compare it with pressure support ventilation (PS).
Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. [2022]Non-invasive positive pressure ventilation (NIPPV) is effective in treating acute exacerbations of chronic obstructive pulmonary disease (COPD). Nocturnal non-invasive positive pressure ventilation (nocturnal-NIPPV) has been proposed as an intervention for stable hypercapnic patients with COPD.
Nocturnal noninvasive positive pressure ventilation in stable COPD: a systematic review and individual patient data meta-analysis. [2022]The effects of nocturnal noninvasive positive pressure ventilation (NIPPV) in patients with stable chronic obstructive pulmonary disease (COPD) remain controversial.
Is There Any Additional Effect of Tele-Assistance on Long-Term Care Programmes in Hypercapnic COPD Patients? A Retrospective Study. [2018]The evidence for tele-assistance (TA) in hypercapnic chronic obstructive pulmonary disease (COPD) patients on long-term oxygen therapy (LTOT) is scarce. The aim of this study was to evaluate the effects of addition of long-term TA to LTOT with or without non-invasive ventilation (NIV) in these patients. Retrospective analysis of a previous randomised study of patients on LTOT. According to the care programme patients were divided into Group 1: LTOT; Group 2: LTOT + NIV; Group 3: LTOT + TA and Group 4: LTOT + NIV+TA.
Early predictors of success of non-invasive positive pressure ventilation in hypercapnic respiratory failure. [2020]Non-invasive positive pressure ventilation (NIPPV) has emerged as a significant advancement in the management of acute hypercapnic respiratory failure.
Noninvasive positive pressure ventilation in the immediate post-bariatric surgery care of patients with obstructive sleep apnea: a systematic review. [2018]Obstructive sleep apnea is common in morbidly obese patients, and noninvasive positive pressure ventilation (NIPPV) is the standard treatment. Postoperatively, NIPPV is highly effective in preventing hypoxia and apneic episodes; however, the concern of gastric distention leading to increased risk of an anastomotic dehiscence limits universal acceptance.
Positional therapy in sleep apnoea - one fits all? What determines success in positional therapy in sleep apnoea syndrome. [2018]Positional therapy is a simple means of therapy in sleep apnoea syndrome, but due to controversial or lacking evidence, it is not widely accepted as appropriate treatment. In this study, we analysed data to positional therapy with regard to successful reduction of AHI and predictors of success.
Sleep-Related Breathing Disorders: When CPAP Is Not Enough. [2022]Three decades ago, continuous positive airway pressure (CPAP) was introduced to treat obstructive sleep apnea (OSA). Shortly after, bilevel positive airway pressure devices (BPAP) that independently adjusted inspiratory and expiratory positive airway pressure were developed to treat complex sleep-related breathing disorders unresponsive to CPAP. Based on the bilevel positive airway pressure platform (hardware) governed by propriety algorithms (software), advanced modes of noninvasive ventilation (NIV) were developed to address complex cardiorespiratory pathophysiology beyond OSA. This review summarizes key aspects of different bilevel PAP therapies (BPAP with/without backup rate, adaptive servoventilation, and volume-assured pressure support) to treat common sleep-related hypoventilation disorders, treatment-emergent central sleep apnea, and central sleep apnea syndromes.
Advances in Treatment of Sleep-Disordered Breathing. [2021]Sleep-disordered breathing, composed of obstructive sleep apnea (OSA) and central sleep apnea (CSA), affects millions of people worldwide carrying with it significant morbidity and mortality. Diagnosis is made by polysomnography, and severity of sleep apnea is determined by the apnea-hypopnea index (AHI). Positive airway pressure (PAP) therapy has been the gold standard in treating both OSA and CSA. PAP therapy can greatly reduce AHI burden as well as morbidity and mortality and improve quality of life.
Adenotonsillotomy versus adenotonsillectomy in pediatric obstructive sleep apnea: A 5-year RCT. [2022]Adenotonsillectomy (ATE) is a common treatment for pediatric obstructive sleep apnea (OSA). Intracapsular adenotonsillotomy (ATT) is associated with less postoperative morbidity. Our previous randomized controlled trial (RCT) compared ATE and ATT in otherwise healthy children with moderate to severe OSA. No differences in polysomnographic (PSG) and OSA-18 were found between the groups at one-year follow-up. This study presents the long-term results of the RCT.