The Effect of CPAP on Lung Hyperinflation in Patients With OSA

January 9, 2020 updated by: Milan Sova, University Hospital Olomouc

The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea

Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rationale:

Obstructive sleep apnoea (OSA) is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation > 50% + blood oxygen desaturation > 3% or airflow limitation > 30% blood oxygen desaturation > 4%). The prevalence of lung hyperinflations in sleep apnoea patients and effect of continuous positive airway pressure (CPAP) therapy is not known.

Process:

Subjects included in the study will be obstructive sleep apnoea (OSA) patients diagnosed by respiratory polysomnography performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc.

Bodypletysmography will be performed in the time of OSA diagnosis and after 3 months of CPAP therapy.

Data will be statistically evaluated after completion of the target number of subjects.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia, 77900
        • University Hospital Olomouc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with obstructive sleep apnoea syndrome indicated for CPAP therapy

Description

Inclusion Criteria:

  • Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)

Exclusion Criteria:

  • - Bilevel positive airway pressure therapy
  • Total lung capacity < 80% lower limit of normal values
  • Obstructive ventilatory disorder
  • Change in body weight ˃ 10%
  • Change in smoking status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Continuous Positive Airway Pressure
Patient treated with continuous positive airway pressure
Device: Continuous Positive Airway Pressure therapy
Standard treatment with continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Vital Capacity (VC) (ml)
Time Frame: 3 months
Percentage change of Vital Capacity after 3 months of CPAP therapy.
3 months
Change of Forced Expiratory Volume in 1 second (FEV1) (ml)
Time Frame: 3 months
Percentage change of Forced Expiratory Volume in 1 second after 3 months of CPAP therapy.
3 months
Change of Total Lung Capacity (TLC) (ml)
Time Frame: 3 months
Percentage change of Total Lung Capacity after 3 months of CPAP therapy.
3 months
Change of Residual Volume (RV) (ml)
Time Frame: 3 months
Percentage change of Residual Volume after 3 months of CPAP therapy.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Investigators

  • Principal Investigator: Milan Sova, MD, Ph.D., Department of Respiratory Medicine, University Hospital Olomouc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2019

Primary Completion (ACTUAL)

January 9, 2020

Study Completion (ACTUAL)

January 9, 2020

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAS_bodypletysmo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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