20 Participants Needed

CPAP for Idiopathic Pulmonary Fibrosis

SP
SC
Overseen BySachin Chaudhary, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Arizona
Must be taking: Nintedanib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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 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.12345

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.12345

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.12367

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.12367

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.12348

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.12348

Who Is on the Research Team?

Sachin Chaudhary, MD | Department of ...

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.
See 4 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.
See 7 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: CPAPExperimental Treatment1 Intervention
Group II: No CPAPActive Control1 Intervention

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

Obstructive sleep apnea should be treated in patients with idiopathic pulmonary fibrosis. [2022]
CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? [2022]
Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. [2022]
Prevalence and clinical impacts of obstructive sleep apnea in patients with idiopathic pulmonary fibrosis: A single-center, retrospective study. [2023]
Morbidity and mortality reduction associated with polysomnography testing in idiopathic pulmonary fibrosis: a population-based cohort study. [2021]
Occupational risk factors for idiopathic pulmonary fibrosis in Southern Europe: a case-control study. [2019]
Sleep and breathing in idiopathic pulmonary fibrosis. [2010]
Novel insights in cough and breathing patterns of patients with idiopathic pulmonary fibrosis performing repeated 24-hour-respiratory polygraphies. [2018]
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