The Effect of CPAP on Lung Hyperinflation in Patients With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04084899
• Other study ID #: OSAS_bodypletysmo
• Status: Completed
• Start date: September 5, 2019
• Est. completion date: January 9, 2020

Study information

• Verified date: January 2020
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Vital Capacity (VC) (ml)	Percentage change of Vital Capacity after 3 months of CPAP therapy.	3 months
Primary	Change of Forced Expiratory Volume in 1 second (FEV1) (ml)	Percentage change of Forced Expiratory Volume in 1 second after 3 months of CPAP therapy.	3 months
Primary	Change of Total Lung Capacity (TLC) (ml)	Percentage change of Total Lung Capacity after 3 months of CPAP therapy.	3 months
Primary	Change of Residual Volume (RV) (ml)	Percentage change of Residual Volume after 3 months of CPAP therapy.	3 months