NCT01637831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

July 4, 2012

Last Update Submit

July 10, 2012

Conditions

Obstructive Sleep ApneaIdiopathic Pulmonary Fibrosis

Keywords

Obstructive Sleep ApneaIdiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with OSA and IPF

EXPERIMENTAL

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)

Interventions

Continuous Positive Airway Pressure (CPAP)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.

Also known as: positive pressure ventilation
Patients with OSA and IPF

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Congestive heart failure
  • Chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heraklion, Crete, 71110, Greece

Location

Related Publications (2)

  • 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.

    PMID: 33108270DERIVED

  • 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.

    PMID: 23386371DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveIdiopathic Pulmonary Fibrosis

Interventions

Continuous Positive Airway PressurePositive-Pressure Respiration

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPulmonary FibrosisLung Diseases, InterstitialLung Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Sophia E Schiza, MD, PhD

    University of Crete

    STUDY CHAIR

  • Charalampos Mermigkis, MD

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

    STUDY DIRECTOR

  • Izolde Bouloukaki, MD, PhD

    University of Crete

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pulmonologist, Sleep Medicine subspecialty

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 11, 2012

Study Start

March 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

GR(1)