Clinical trial NCT01637831: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Idiopathic Pulmonary Fibrosis
Keywords: Obstructive Sleep Apnea
Idiopathic Pulmonary Fibrosis
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Congestive heart failure
* Chronic renal failure

Primary outcomes:
measure: Change in overal quality of life parameters in IPF patients with OSA after the start of effective CPAP treatment
timeFrame: Day 1, Month 1, 3 and Month 6 post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
state: Crete
Study officials:
affiliation: University of Crete
name: Sophia E Schiza, MD, PhD
role: STUDY_CHAIR
affiliation: Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
name: Charalampos Mermigkis, MD
role: STUDY_DIRECTOR
affiliation: University of Crete
name: Izolde Bouloukaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.