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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how using a CPAP machine (a device that keeps airways open during sleep) affects individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring, who also have sleep apnea. Researchers aim to determine if CPAP can reduce lung inflammation and balance esophageal pH (acid levels in the esophagus). Participants either use the CPAP device for a few weeks or do not use it to compare results. Suitable candidates have been diagnosed with IPF, are likely to have sleep apnea, and are already taking or will start taking the medication nintedanib for IPF. As an unphased trial, this study provides a unique opportunity to contribute to understanding how CPAP might improve lung health in IPF patients.

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 prior data suggests that CPAP is safe for patients with idiopathic pulmonary fibrosis and sleep apnea?

Research has shown that CPAP (continuous positive airway pressure) therapy is generally safe for people with idiopathic pulmonary fibrosis (IPF) and sleep apnea. CPAP is a common treatment for sleep apnea, and studies have found it beneficial for those with IPF as well.

For instance, one study found that people who used CPAP regularly had better survival rates over two years. This finding suggests that the treatment is well-tolerated and can even improve quality of life by making daily activities easier. No major reports of serious side effects or negative impacts on lung function have emerged over time.

In summary, CPAP therapy is considered safe and may help those with IPF and sleep apnea. Participants should follow their healthcare provider's advice and report any unusual symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using CPAP (Continuous Positive Airway Pressure) for idiopathic pulmonary fibrosis because it offers a non-invasive method to potentially improve breathing during sleep. Unlike standard treatments for this condition, which often include medications like antifibrotic drugs to slow lung damage, CPAP focuses on enhancing nighttime oxygenation directly. This approach could provide symptomatic relief and improve quality of life without relying on additional medications, which often come with side effects. By supporting the airway during sleep, CPAP might help alleviate breathlessness and improve sleep quality, which are significant concerns for patients with this condition.

What evidence suggests that CPAP is effective for idiopathic pulmonary fibrosis?

Research has shown that CPAP, a machine that aids breathing during sleep, benefits people with idiopathic pulmonary fibrosis (IPF) and sleep apnea. Studies have found that CPAP users feel less sleepy and tired, sleep better, and experience fewer health problems related to their condition. Some research suggests that CPAP might improve nighttime breathing, potentially leading to better long-term health for IPF patients. In this trial, participants in the CPAP treatment arm will use continuous positive airway pressure via an autoPAP device while sleeping for 4-8 weeks. Overall, CPAP effectively manages sleep issues in people with IPF. ^{3 6 7 8 9}

Who Is on the Research Team?

Sachin Chaudhary, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23386371/

CPAP therapy in patients with idiopathic pulmonary fibrosis ... Results: A statistically significant improvement was observed in the FOSQ at 1, 3, and 6 months after CPAP initiation (baseline 12.9 ± 2.9 vs. 14.7 ± 2.6 vs.

2. mdpi.com mdpi.com/2077-0383/11/17/5008

The Association between Idiopathic Pulmonary Fibrosis ... CPAP therapy could mitigate nocturnal desaturations and therefore may improve the prognosis of IPF [81]. Effective CPAP therapy is proven to ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8932

Patients with idiopathic pulmonary fibrosis with and without ... Effective PAP treatment in these patients results in a significant improvement in sleepiness, fatigue, poor sleep quality, mortality, and exacerbations.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01637831

CPAP Therapy in Patients With Idiopathic Pulmonary ... Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33108270/

Patients with idiopathic pulmonary fibrosis with and without ... Effective positive airway pressure treatment results in a significant improvement in sleepiness, fatigue, sleep quality, and mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11186220/

Treating sleep-disordered breathing of idiopathic pulmonary ... There were no significant differences in lung function after one year. Other studies treating patients with IPF and OSA by CPAP did not measure ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9457448/

The Association between Idiopathic Pulmonary Fibrosis and ... Another positive effect of CPAP therapy may be a positive effect in decreasing pulmonary hypertension correlated with OSA and potentially in IPF ...

8. publications.ersnet.org publications.ersnet.org/content/errev/24/136/327

Idiopathic pulmonary fibrosis and sleep disorders: no longer ... Effective CPAP treatment in IPF patients with OSA resulted in a significant improvement in daily living activities based on the Functional Outcome of Sleep ...

9. withpower.com withpower.com/trial/phase-pulmonary-fibrosis-9-2019-2bc4b

CPAP for Idiopathic Pulmonary Fibrosis · Info for Participants 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 ...