CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

The recent literature shows an increased incidence of obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF). On the other hand there are no published studies related to CPAP treatment in this patient group. The investigators aim was to assess the effect of CPAP on sleep and overall life quality parameters in IPF patients with OSA and to recognize and overcome possible difficulties in CPAP initiation and acceptance by these patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Nervous System Diseases Pulmonary Fibrosis Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete

Heraklion, Crete, 71110, Greece

About this study

Recently published studies report a high incidence of obstructive sleep apnea (OSA) in patients with IPF. Underlying, and usually under-diagnosed OSA in these patients may be a reason for impaired sleep quality and may consequently have a negative influence on their daily activities and overall quality of life. In addition, underlying OSA may have a negative influence on the already impaired IPF-related morbidity and mortality. The absence of any effective treatment for IPF so far indicates that the recognition and treatment of generally under-diagnosed OSA in IPF patients should be a primary goal. Therefore, our primary aim in this study was to assess the results of effective CPAP therapy in terms of sleep quality and overall quality of life in IPF patients with moderate to severe OSA. The investigators used generally accepted instruments to assess quality of sleep and overall life. In addition, the investigators tried to determine and overcome the reasons for poor CPAP compliance in these patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with apnoea-hypopnoea index >15/h
Newly diagnosed IPF

Exclusion criteria

Congestive heart failure
Chronic renal failure

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Procedure

Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment completion of questionnaires assessing sleep and quality of life 1, 3 and 6 months after the start of effective CPAP treatment.

Other names: positive pressure ventilation

Primary outcomes

Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment

Time frame: Day 1, Month 1, 3 and Month 6 post treatment

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea. Does It Offer a Better Quality of Life and Sleep?

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jul 11, 2012
Registry last updated: Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed