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CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea

NCT ID: NCT01637831

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea Idiopathic Pulmonary Fibrosis

Keywords

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Obstructive Sleep Apnea Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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positive pressure ventilation

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Congestive heart failure
* Chronic renal failure
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Crete

OTHER

Sponsor Role lead

Responsible Party

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Charalampos Mermigkis

Pulmonologist, Sleep Medicine subspecialty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophia E Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

Charalampos Mermigkis, MD

Role: STUDY_DIRECTOR

Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece

Izolde Bouloukaki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Crete

Locations

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Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete

Heraklion, Crete, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 33108270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23386371 (View on PubMed)

Other Identifiers

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CPAPIPF-02

Identifier Type: -

Identifier Source: org_study_id