Obstructive Sleep ApneaNCT04084899
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure therapy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Sep 2019to 9 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obstructive sleep apnoea syndrome indicated for CPAP therapy
Who may be able to join
- Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea
Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure therapy
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Lung hyperinflation
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure therapyDevice
Standard treatment with continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Patient treated with continuous positive airway pressure Receives: Device: Continuous Positive Airway Pressure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Vital Capacity (VC) (ml)
Percentage change of Vital Capacity after 3 months of CPAP therapy.
Measured: 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.
Measured: 3 months
Change of Total Lung Capacity (TLC) (ml)
Percentage change of Total Lung Capacity after 3 months of CPAP therapy.
Measured: 3 months
Change of Residual Volume (RV) (ml)
Percentage change of Residual Volume after 3 months of CPAP therapy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start5 Sep 2019
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milan Sova, University Hospital Olomouc
- Investigators
- Milan Sova, MD, Ph.D., Principal investigator, Department of Respiratory Medicine, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084899
- Sponsor's protocol ID
- OSAS_bodypletysmo
- Status last verified
- Jan 2020
- First submitted
- 5 Sep 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT04084899
- Acronym / sponsor ID
- OSAS_bodypletysmo
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Lung hyperinflation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | – | Device: Continuous Positive Airway Pressure therapyPatient treated with continuous positive airway pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstructive sleep apnoea syndrome indicated for CPAP therapy
Key inclusion criteria (1 listed)
- Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure therapyStandard treatment with continuous positive airway pressure | Device | Continuous Positive Airway Pressure |
Primary outcome
Change of Vital Capacity (VC) (ml)
Time frame: 3 months
Percentage change of Vital Capacity after 3 months of CPAP therapy.
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.
Change of Total Lung Capacity (TLC) (ml)
Time frame: 3 months
Percentage change of Total Lung Capacity after 3 months of CPAP therapy.
Change of Residual Volume (RV) (ml)
Time frame: 3 months
Percentage change of Residual Volume after 3 months of CPAP therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan Sova, MD, Ph.D. principal investigator
Department of Respiratory Medicine, University Hospital Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Vital Capacity (VC) (ml) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.