- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084899
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Olomouc, Czechia, 77900
- University Hospital Olomouc
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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Standard treatment with continuous positive airway pressure
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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
Sponsor
Investigators
- Principal Investigator: Milan Sova, MD, Ph.D., Department of Respiratory Medicine, University Hospital Olomouc
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSAS_bodypletysmo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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