CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637831
• Other study ID #: CPAPIPF-02
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: July 10, 2012
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with apnoea-hypopnoea index >15/h

• Newly diagnosed IPF

Exclusion Criteria:

• Congestive heart failure

• Chronic renal failure

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Obstructive Sleep Apnea
• Pulmonary Fibrosis
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Continuous Positive Airway Pressure (CPAP)
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.

Locations

Country	Name	City	State
Greece	Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No