CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Patients with apnoea-hypopnoea index >15/h
- Newly diagnosed IPF
Exclusion Criteria:
- Congestive heart failure
- Chronic renal failure
Sites / Locations
- Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with OSA and IPF
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01637831
Brief Title
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea
Official Title
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Obstructive Sleep Apnea. Does It Offer a Better Quality of Life and Sleep?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
Keywords
Obstructive Sleep Apnea, Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with OSA and IPF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Other Intervention Name(s)
positive pressure ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with apnoea-hypopnoea index >15/h
Newly diagnosed IPF
Exclusion Criteria:
Congestive heart failure
Chronic renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia E Schiza, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charalampos Mermigkis, MD
Organizational Affiliation
Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Izolde Bouloukaki, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
33108270
Citation
Papadogiannis G, Bouloukaki I, Mermigkis C, Michelakis S, Ermidou C, Mauroudi E, Moniaki V, Tzanakis N, Antoniou KM, Schiza SE. Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment. J Clin Sleep Med. 2021 Mar 1;17(3):533-544. doi: 10.5664/jcsm.8932.
Results Reference
derived
PubMed Identifier
23386371
Citation
Mermigkis C, Bouloukaki I, Antoniou KM, Mermigkis D, Psathakis K, Giannarakis I, Varouchakis G, Siafakas N, Schiza SE. CPAP therapy in patients with idiopathic pulmonary fibrosis and obstructive sleep apnea: does it offer a better quality of life and sleep? Sleep Breath. 2013 Dec;17(4):1137-43. doi: 10.1007/s11325-013-0813-8. Epub 2013 Feb 6.
Results Reference
derived
Learn more about this trial
CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea
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