Positive Airway Pressure Therapy for Overlap Syndrome

Recruiting at 1 trial location

Overseen By Ruchi Rastogi, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Sedatives, Stimulants

Disqualifiers: Neuromuscular diseases, PTSD, Narcolepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

668 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of positive airway pressure therapy on individuals with Overlap Syndrome, a combination of sleep apnea and COPD. The researchers aim to determine if this treatment can improve symptoms such as poor sleep and reduced quality of life, which are common in Veterans with this condition. Participants will either receive the therapy or continue with their usual care and education about sleep. Veterans with moderate to severe sleep apnea and COPD, along with a history of smoking, may be suitable candidates for this study. As an unphased trial, this study provides Veterans the chance to contribute to valuable research that could enhance treatment options for Overlap Syndrome.

Will I have to stop taking my current medications?

The trial requires that participants have a stable treatment regimen for COPD, so you should not stop your current COPD medications. However, if you are taking medicines that cause or alter sleepiness, like sedative hypnotics or stimulants, you may need to stop those as they are excluded from the trial.

What prior data suggests that positive airway pressure therapy is safe for patients with Overlap Syndrome?

Research has shown that therapies like CPAP (Continuous Positive Airway Pressure) and BiPAP (Bilevel Positive Airway Pressure) are generally safe for individuals with obstructive sleep apnea and COPD. Studies indicate that these therapies can improve breathing and reduce symptoms. Most patients tolerate the treatment well, experiencing only minor side effects.

However, rare complications, such as air trapped in the brain (pneumocephalus), have been reported, though these are uncommon. Overall, positive airway pressure therapy is widely used and considered a safe option for enhancing sleep and breathing in patients with overlap syndrome. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Positive Airway Pressure (PAP) therapy for overlap syndrome because it offers a targeted approach to managing this condition. Overlap syndrome, which combines features of both obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD), is traditionally managed with separate treatments for each condition. PAP therapy stands out because it directly addresses the breathing issues associated with both OSA and COPD simultaneously, potentially improving outcomes for patients by enhancing sleep quality and respiratory function. This integrated approach could offer a more cohesive and efficient treatment option compared to managing each condition separately.

What evidence suggests that positive airway pressure therapy might be an effective treatment for Overlap Syndrome?

Studies have shown that positive airway pressure (PAP) therapy can benefit individuals with overlap syndrome, a condition involving both obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD). In this trial, some participants will receive PAP therapy, which research indicates often improves sleep and reduces symptom severity. People using PAP therapy have reported feeling less sleepy during the day and experiencing fewer health issues related to these conditions. One study found that PAP therapy can lower blood pressure and reduce car accidents caused by sleepiness. Overall, PAP therapy offers a promising approach to managing the challenging symptoms of overlap syndrome. Meanwhile, other participants in this trial will receive conservative care, including education about sleep apnea and sleep hygiene. ^{3 6 7 8 9}

Who Is on the Research Team?

Susmita Chowdhuri, MD

Principal Investigator

John D. Dingell VA Medical Center, Detroit, MI

Are You a Good Fit for This Trial?

This trial is for veterans aged 60 or older with moderate-to-severe obstructive sleep apnea and chronic obstructive pulmonary disease, who have a significant history of smoking. They must not have used positive airway pressure before, be on stable COPD treatment, and not suffer from severe conditions that could affect cognitive function or safety.

Inclusion Criteria

My COPD treatment has not changed recently.

I am 60 years old or older.

I have severe sleep apnea and COPD, and I've smoked significantly in the past.

Exclusion Criteria

Pregnant women due to unknown risks

I am not taking medications that could affect my sleepiness.

I am currently experiencing severe depression or have unstable mental health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PAP therapy or conservative care to study its effects on sleep quality, neurocognitive function, and quality of life

6 months

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Conservative care
• Positive airway pressure

Trial Overview The study tests if using positive airway pressure therapy can improve life quality, sleep quality, and neurocognitive function in older veterans with Overlap Syndrome (both OSA and COPD). Participants will either receive standard care or the addition of this therapy.

How Is the Trial Designed?

Group I: Conservative care (control arm) Experimental Treatment 1 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.

Group II: PAP therapy arm Active Control 1 Intervention

PAP Therapy will be provided to eligible patients with OVS. This is the active therapy arm.

Positive airway pressure is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Mixed Sleep Apnea

Approved in European Union as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Mixed Sleep Apnea

Approved in Canada as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Mixed Sleep Apnea

Approved in Japan as CPAP for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Mixed Sleep Apnea

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 35 patients with moderate to severe obstructive sleep apnea (OSA), both Continuous Positive Airway Pressure (CPAP) and Auto Bi-level Pressure Relief-Positive Airway Pressure (ABPR-PAP) significantly reduced the apnea-hypopnea index (AHI), indicating effective treatment.

After 3 months, ABPR-PAP showed a comparable reduction in AHI to CPAP, with no significant differences in compliance or adverse events, suggesting that ABPR-PAP could be a comfortable alternative for patients who struggle with traditional CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto bi-level pressure relief-PAP is as effective as CPAP in OSA patients--a pilot study. Blau, A., Minx, M., Peter, JG., et al.[2021]

In a study of 28 patients who struggled with CPAP compliance due to pressure intolerance, both a new CPAP and a Bi-level PAP device improved usage significantly, with Bi-level PAP showing a trend towards better compliance (2.73 hours vs. 2.23 hours for new CPAP).

Despite the improvements in compliance, the overall effectiveness of Bi-level PAP for this group was not significantly better than new CPAP, although some patients with exhalation difficulties did show favorable trends with the Bi-level PAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of changing people with sleep apnea using CPAP less than 4 h per night to a Bi-level device. Gulati, A., Oscroft, N., Chadwick, R., et al.[2015]

In a study of 319 elderly patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) who started positive airway pressure (PAP) therapy, hospitalization rates for COPD-related conditions significantly decreased from 25.4% to 19.4% in the year following treatment.

While PAP therapy did not significantly reduce overall emergency room visits or all-cause hospitalizations, it was particularly beneficial for older adults and those with more complex COPD and multiple comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of PAP therapy on hospitalization rates in Medicare beneficiaries with COPD and coexisting OSA. Singh, G., Agarwal, A., Zhang, W., et al.[2021]

The overlap syndrome, which involves both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), has shown improved patient outcomes when treated with continuous positive airway pressure (CPAP), including better survival rates and fewer exacerbations.

It is recommended that physicians screen COPD patients for OSA and consider starting CPAP treatment promptly for those diagnosed with OSA, as this could enhance their overall health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in the management of chronic obstructive pulmonary disease and the overlap syndrome. Kouns, A., Phillips, B.[2021]

In a study of 54 patients with sleep apnoea/hypopnoea syndrome, the average nightly usage of CPAP therapy was only 4.7 hours, which is less than the recommended duration for effective treatment.

There was no correlation between the severity of sleep apnoea and the amount of CPAP used, and patients who experienced side effects from the therapy tended to use it significantly less, highlighting the importance of monitoring and addressing side effects to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Engleman, HM., Martin, SE., Douglas, NJ.[2019]

A case report highlights a rare but serious complication of using BiPAP after surgery for a brain tumor, where the patient developed severe pneumocephalus, leading to an unplanned ICU admission.

The authors recommend caution when using CPAP or BiPAP in postoperative patients, especially those who have undergone head and neck procedures, due to potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumocephalus with BiPAP use after transsphenoidal surgery. Kopelovich, JC., de la Garza, GO., Greenlee, JD., et al.[2022]

Long-term nonadherence to CPAP therapy in patients with obstructive sleep apnea is linked to factors such as using CPAP for less than 4 hours per night, having moderate to severe sleep apnea, low self-efficacy, and lack of support from a bed partner.

The American Academy of Sleep Medicine recommends follow-up within the first two weeks of CPAP use to enhance adherence, emphasizing the need for an integrated approach that includes behavioral therapy and management of side effects, while pharmacologic options like sedative-hypnotics are less favored due to potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea. Shaukat, R., Gamal, Y., Ali, A., et al.[2022]

Overlap syndrome, which involves both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), leads to more severe health issues such as increased hypoxemia, hypercapnea, pulmonary hypertension, and right heart failure compared to COPD alone.

It is crucial to actively screen for overlap syndrome in COPD patients and treat it with continuous positive airway pressure (CPAP) alongside oxygen therapy and appropriate COPD medications to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The overlap syndrome: obstructive sleep apnea and chronic obstructive pulmonary disease]. Shteinberg, M., Weiler-Ravel, D., Adir, Y.[2009]

In a study of 32 hypercapnic overlap syndrome patients with moderate-to-severe obstructive sleep apnea, auto-trilevel positive airway pressure (PAP) therapy was found to be more effective than conventional Bilevel PAP therapy in reducing apnea events and carbon dioxide retention, leading to improved sleep quality.

Auto-trilevel PAP therapy resulted in lower arousal indices and daytime sleepiness, while also achieving higher minimum oxygen saturation levels during sleep, indicating it may be a better treatment option for patients who do not respond well to standard Bilevel PAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto-trilevel versus bilevel positive airway pressure ventilation for hypercapnic overlap syndrome patients. Su, M., Huai, D., Cao, J., et al.[2019]

In a study of 21 patients with overlap syndrome and hypercapnia, Auto-trilevel PAP ventilation significantly reduced the number of apnea-hypopnea events and improved sleep quality compared to fixed BiPAP ventilation.

Auto-trilevel PAP also effectively lowered morning carbon dioxide levels and daytime sleepiness, demonstrating its superiority in managing hypercapnic overlap syndrome and enhancing overall patient comfort during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of auto-trilevel positive airway ventilation in hypercapnic patients with overlap syndrome]. Quan, W., Ding, N., Dong, Y., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807907/

A pilot randomized trial comparing CPAP vs bilevel PAP ... This pilot study aims to compare the efficacy of continuous positive airway pressure vs bilevel positive airway pressure spontaneous mode in the treatment of ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945723001946

The use of continuous positive airway pressure in COPD ... Our systematic review suggests that CPAP therapy is effective in improving outcomes in patients with COPD-OSA overlap syndrome.

3. atsjournals.org atsjournals.org/doi/10.1164/rccm.202109-2035OC

Impact of Positive Airway Pressure Therapy Adherence on ... This retrospective observational study investigated the effects of PAP on health outcomes, resource usage, and costs in patients with overlap syndrome.

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7638

Treatment of Adult Obstructive Sleep Apnea With Positive ... PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor vehicle accidents.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8409567/

A review of therapies for the overlap syndrome of obstructive ... The article provides an overview of the pathogenesis, associated risk factors, prevalence, and management of sleep‐related breathing disorders in COPD.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01427673

Continuous Positive Airway Pressure Versus Noninvasive ... Continuous Positive Airway Pressure Versus Noninvasive Ventilation in Patients With Overlap Syndrome (OS). ClinicalTrials.gov ID NCT01427673.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11388228/

Prognostic efficacy of non-invasive ventilation in patients with ... Patients with overlap syndrome (OS) exhibit ventilatory defects in both lower and upper airway and experience more adverse outcomes, including ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00914264

The Effects of Continuous Positive Airway Pressure on ... The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic ...

9. withpower.com withpower.com/trial/phase-syndrome-11-2020-cd119

Positive Airway Pressure Therapy for Overlap Syndrome Positive Airway Pressure Therapy, including CPAP and BiPAP, is generally considered safe for humans. However, rare complications like pneumocephalus (air ...