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Completed

NCT Number: NCT04084899

The Effect of CPAP on Lung Hyperinflation in Patients With OSA

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure Therapy

Device

Standard treatment with continuous positive airway pressure

Primary outcomes

  1. Change of Vital Capacity (VC) (ml)

    Time frame: 3 months

    Percentage change of Vital Capacity after 3 months of CPAP therapy.

  2. 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. Change of Total Lung Capacity (TLC) (ml)

    Time frame: 3 months

    Percentage change of Total Lung Capacity after 3 months of CPAP therapy.

  4. Change of Residual Volume (RV) (ml)

    Time frame: 3 months

    Percentage change of Residual Volume after 3 months of CPAP therapy.

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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