The Effect of CPAP on Lung Hyperinflation in Patients With OSA

Overview

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

Full Title of Study: “The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2019

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.

Interventions

  • Device: Continuous Positive Airway Pressure therapy
    • Standard treatment with continuous positive airway pressure

Arms, Groups and Cohorts

  • Continuous Positive Airway Pressure
    • Patient treated with continuous positive airway pressure

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Olomouc
  • Provider of Information About this Clinical Study
    • Principal Investigator: Milan Sova, Principal Investigator, Head of Sleep Laboratory, Department of Respiratory Medicine – University Hospital Olomouc
  • Overall Official(s)
    • Milan Sova, MD, Ph.D., Principal Investigator, Department of Respiratory Medicine, University Hospital Olomouc
  • Overall Contact(s)
    • Samuel Genzor, MD, +420588445179, samuel.genzor@fnol.cz

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