CPAP for Idiopathic Pulmonary Fibrosis

Overseen By Sachin Chaudhary, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must be taking: Nintedanib

Must not be taking: Anticoagulants

Disqualifiers: Other lung diseases, Severe illness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4-8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on nintedanib or start it before joining the study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you either be on nintedanib or start it before joining the study.

What data supports the idea that CPAP for Idiopathic Pulmonary Fibrosis (also known as: CPAP) is an effective treatment?

The available research shows that there is a lack of studies specifically examining the effectiveness of CPAP for Idiopathic Pulmonary Fibrosis (IPF). However, it is noted that obstructive sleep apnea (OSA) is common in IPF patients and is linked to worse outcomes. While CPAP is used to treat OSA, there is no direct evidence from the provided research that CPAP improves life quality or reduces mortality in IPF patients. The studies call for more research to determine the potential benefits of CPAP for these patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment CPAP for idiopathic pulmonary fibrosis?

Research suggests that CPAP (a machine that helps keep your airways open while you sleep) may improve sleep quality and overall life quality in patients with idiopathic pulmonary fibrosis (IPF) who also have obstructive sleep apnea (OSA). However, there is a lack of direct studies on CPAP's effectiveness specifically for IPF without OSA, indicating a need for more research. ^{1 2 3 4 5}

What safety data exists for CPAP treatment in idiopathic pulmonary fibrosis?

The available research highlights a lack of published studies specifically addressing the safety of CPAP treatment in patients with idiopathic pulmonary fibrosis (IPF) and obstructive sleep apnea (OSA). The studies call for more intensive research in this area to assess the effects of CPAP on sleep quality, life quality, morbidity, and mortality in this patient group. Therefore, current safety data is limited, and further studies are needed to establish comprehensive safety profiles. ^{1 2 3 5 6}

Is CPAP generally safe for humans?

The research does not provide specific safety data for CPAP in idiopathic pulmonary fibrosis, but CPAP is commonly used for treating obstructive sleep apnea and is generally considered safe for humans. ^{1 2 3 5 6}

Is CPAP a promising treatment for idiopathic pulmonary fibrosis?

CPAP, which stands for continuous positive airway pressure, is a promising treatment for people with idiopathic pulmonary fibrosis (IPF) who also have obstructive sleep apnea (OSA). It can improve sleep quality and overall life quality for these patients. By helping them breathe better at night, CPAP may also reduce the risk of health problems related to poor sleep. ^{1 2 3 7 8}

How does CPAP treatment differ from other treatments for idiopathic pulmonary fibrosis?

CPAP (continuous positive airway pressure) is unique for idiopathic pulmonary fibrosis (IPF) patients with obstructive sleep apnea (OSA) because it focuses on improving sleep quality and overall life quality, which are often affected by sleep disorders in these patients. Unlike other treatments that may not effectively address sleep-related issues, CPAP specifically targets breathing problems during sleep, potentially enhancing the patient's quality of life. ^{1 2 3 7 8}

Research Team

Sachin Chaudhary, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for people with idiopathic pulmonary fibrosis (IPF) and suspected sleep apnea, who can handle a CPAP machine and are on or starting nintedanib treatment. They must be able to undergo 24hr pH monitoring, provide consent, and follow the study plan. It's not for those with severe lung diseases other than IPF, recent nasal surgery, or life expectancy less than a year.

Inclusion Criteria

I can follow through with CPAP treatment.

My condition is officially diagnosed as IPF according to 2018 guidelines.

You are likely to have obstructive sleep apnea based on the STOP-BANG measure, with a score of 3 or more.

Exclusion Criteria

I was diagnosed with a recent worsening of my lung condition but have since recovered.

Your lung function test shows a specific ratio that indicates obstructive lung disease.

I cannot tolerate nintedanib due to side effects.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP treatment or no treatment for 4-8 weeks, with overnight sleep studies and 24-hour pH monitoring

4-8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in lung inflammation biomarkers and esophageal pH over 6 months

6 months

1 visit (in-person)

Treatment Details

Interventions

• CPAP

Trial Overview The study tests if using a CPAP machine at night can help reduce acid reflux and lung inflammation in patients who have both IPF and sleep apnea. Participants will use CPAP therapy alongside their usual IPF treatment with nintedanib.

Participant Groups

Group I: CPAP Experimental Treatment 1 Intervention

Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.

Group II: No CPAP Active Control 1 Intervention

Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

In a study of 92 newly diagnosed idiopathic pulmonary fibrosis (IPF) patients, those with obstructive sleep apnea (OSA) who adhered well to continuous positive airway pressure (CPAP) treatment showed significant improvements in quality of life and sleep after one year.

Patients with good CPAP compliance had better survival rates, as none died during the 24-month follow-up, while three patients from the poor compliance group did, highlighting the importance of early OSA treatment in IPF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea should be treated in patients with idiopathic pulmonary fibrosis. Mermigkis, C., Bouloukaki, I., Antoniou, K., et al.[2022]

In a study of 12 patients with idiopathic pulmonary fibrosis (IPF) and obstructive sleep apnea (OSA), continuous positive airway pressure (CPAP) therapy significantly improved daily living activities as measured by the Functional Outcomes in Sleep Questionnaire (FOSQ) over 6 months.

Despite improvements in quality of life indicators, challenges with CPAP compliance were noted, with two patients discontinuing use due to issues like nocturnal cough and claustrophobia, highlighting the need for close follow-up and support for effective treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? Mermigkis, C., Bouloukaki, I., Antoniou, KM., et al.[2022]

Patients with idiopathic pulmonary fibrosis (IPF) who also have obstructive sleep apnea (OSA) experience worse quality of life and more severe functional impairments compared to those without OSA, as shown by various health questionnaires.

Using positive airway pressure (PAP) treatment for at least 6 hours significantly improves survival rates and quality of life measures, including sleepiness and fatigue, in patients with IPF-OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. Papadogiannis, G., Bouloukaki, I., Mermigkis, C., et al.[2022]

In a study of 167 patients with idiopathic pulmonary fibrosis (IPF), 64.7% were found to have obstructive sleep apnea (OSA), with older age, higher body weight, and a high-risk score on the Berlin questionnaire identified as independent risk factors for OSA.

The study also revealed that factors such as shorter six-minute walk distance, acute exacerbations, and lower oxygen saturation during sleep were significantly associated with increased mortality risk in IPF patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and clinical impacts of obstructive sleep apnea in patients with idiopathic pulmonary fibrosis: A single-center, retrospective study. Lee, JH., Jang, JH., Park, JH., et al.[2023]

In a study of 5044 individuals with idiopathic pulmonary fibrosis (IPF), those who underwent polysomnography had significantly lower rates of respiratory-related hospitalizations (hazard ratio 0.43) and all-cause mortality (hazard ratio 0.49) compared to those who did not receive the test.

The findings suggest that diagnosing and treating sleep breathing disorders through polysomnography may improve health outcomes for individuals with IPF, indicating its potential role in disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity and mortality reduction associated with polysomnography testing in idiopathic pulmonary fibrosis: a population-based cohort study. Vozoris, NT., Wilton, AS., Austin, PC., et al.[2021]

The study found that certain occupations, such as farmers, veterinarians, and metallurgical workers, are significantly associated with an increased risk of developing the usual interstitial pneumonia (UIP) pattern in idiopathic pulmonary fibrosis (IPF), with odds ratios indicating a strong link.

Exposure to metal dust, fumes, and organic dust was identified as risk factors for UIP, and longer durations of exposure in these high-risk jobs further increased the likelihood of developing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational risk factors for idiopathic pulmonary fibrosis in Southern Europe: a case-control study. Paolocci, G., Folletti, I., Torén, K., et al.[2019]

Patients with idiopathic pulmonary fibrosis (IPF) often experience significant sleep disturbances, which can worsen their quality of life due to factors like coughing and oxygen desaturations during sleep.

There are currently no evidence-based guidelines for managing sleep disorders in IPF, but addressing these issues is crucial for improving patients' overall well-being, especially since effective treatments for IPF itself are limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and breathing in idiopathic pulmonary fibrosis. Rasche, K., Orth, M.[2010]

In a pilot study of 9 patients with idiopathic pulmonary fibrosis (IPF), cough was found to be significantly more frequent during wakefulness (median cough-index of 14.8/h) compared to sleep (1.6/h), highlighting the impact of IPF on daily life.

Despite stable pulmonary function over 8 months, the respiratory rate increased significantly during wakefulness, suggesting that monitoring respiratory rate could be a useful clinical parameter for assessing IPF progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel insights in cough and breathing patterns of patients with idiopathic pulmonary fibrosis performing repeated 24-hour-respiratory polygraphies. Schertel, A., Funke-Chambour, M., Geiser, T., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea should be treated in patients with idiopathic pulmonary fibrosis. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prevalence and clinical impacts of obstructive sleep apnea in patients with idiopathic pulmonary fibrosis: A single-center, retrospective study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Morbidity and mortality reduction associated with polysomnography testing in idiopathic pulmonary fibrosis: a population-based cohort study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Occupational risk factors for idiopathic pulmonary fibrosis in Southern Europe: a case-control study. [2019]

7. Poland pubmed.ncbi.nlm.nih.gov

Sleep and breathing in idiopathic pulmonary fibrosis. [2010]

8. England pubmed.ncbi.nlm.nih.gov

Novel insights in cough and breathing patterns of patients with idiopathic pulmonary fibrosis performing repeated 24-hour-respiratory polygraphies. [2018]