CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis
• Interventions: Procedure: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT01637831
• Lead Sponsor: University of Crete

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-10
• Last Update Submitted: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Congestive heart failure
• Chronic renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with OSA and IPF	Continuous Positive Airway Pressure (CPAP)	Participants with Obstructive Sleep Apnea (OSA)and Idiopathic Pulmonary Fibrosis (IPF).This arm will complete pre-treatment questionnaires assessing sleep and quality of life, undergo six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and complete post-treatment the same questionnaires 1, 3 and 6 months later.

Primary Outcome Measures

Name	Time	Method
Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment	Day 1, Month 1, 3 and Month 6 post treatment

Trial Locations

Locations (1)

Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete; 🇬🇷 Heraklion, Crete, Greece