The Effect of CPAP on Lung Hyperinflation in Patients With OSA

NCT ID: NCT04084899

Last Updated: 2020-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-05

Study Completion Date

2020-01-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Continuous Positive Airway Pressure

Patient treated with continuous positive airway pressure

Continuous Positive Airway Pressure therapy

Intervention Type DEVICE

Standard treatment with continuous positive airway pressure

Interventions

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Continuous Positive Airway Pressure therapy

Standard treatment with continuous positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Milan Sova

Principal Investigator, Head of Sleep Laboratory, Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milan Sova, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Medicine, University Hospital Olomouc

Locations

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University Hospital Olomouc

Olomouc, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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OSAS_bodypletysmo

Identifier Type: -

Identifier Source: org_study_id

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