NCT04084899

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

September 5, 2019

Last Update Submit

January 9, 2020

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaContinuous Positive Airway PressureLung hyperinflation

Outcome Measures

Primary Outcomes (4)

  • Change of Vital Capacity (VC) (ml)

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

    3 months

  • 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

  • Change of Total Lung Capacity (TLC) (ml)

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

    3 months

  • Change of Residual Volume (RV) (ml)

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

    3 months

Study Arms (1)

Continuous Positive Airway Pressure

Patient treated with continuous positive airway pressure

Device: Continuous Positive Airway Pressure therapy

Interventions

Continuous Positive Airway Pressure therapyDEVICE

Standard treatment with continuous positive airway pressure

Continuous Positive Airway Pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with obstructive sleep apnoea syndrome indicated for CPAP therapy

You may qualify if:

  • Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Milan Sova, MD, Ph.D.

    Department of Respiratory Medicine, University Hospital Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Head of Sleep Laboratory, Department of Respiratory Medicine

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

September 5, 2019

Primary Completion

January 9, 2020

Study Completion

January 9, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

CZ(1)