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CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charalampos Mermigkis, University of Crete
ClinicalTrials.gov Identifier:
NCT01637831
First received: July 4, 2012
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Idiopathic Pulmonary Fibrosis
Procedure: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea. Does It Offer a Better Quality of Life and Sleep?

Resource links provided by NLM:


Further study details as provided by University of Crete:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with OSA and IPF
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.
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.
Other Name: positive pressure ventilation

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Congestive heart failure
  • Chronic renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637831

Locations
Greece
Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
Heraklion, Crete, Greece, 71110
Sponsors and Collaborators
University of Crete
Investigators
Study Chair: Sophia E Schiza, MD, PhD University of Crete
Study Director: Charalampos Mermigkis, MD Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Principal Investigator: Izolde Bouloukaki, MD, PhD University of Crete
  More Information

No publications provided

Responsible Party: Charalampos Mermigkis, Pulmonologist, Sleep Medicine subspecialty, University of Crete
ClinicalTrials.gov Identifier: NCT01637831     History of Changes
Other Study ID Numbers: CPAPIPF-02
Study First Received: July 4, 2012
Last Updated: July 10, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Crete:
Obstructive Sleep Apnea
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Apnea
Fibrosis
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Idiopathic Interstitial Pneumonias
Lung Diseases
Lung Diseases, Interstitial
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014