- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07554430
IOS Parameters and PAP Titration Pressure in Obstructive Sleep Apnea (IOS-PAP)
Impulse Oscillometry for Prediction of PAP Titration Pressure in Obstructive Sleep Apnea (IOS-PAP Study)
This prospective observational study aims to investigate whether impulse oscillometry (IOS)-a non-invasive lung function test-can help predict the specific pressure settings needed for positive airway pressure (PAP) therapy in patients with obstructive sleep apnea (OSA).
Currently, finding the optimal therapeutic pressure for OSA patients typically requires a titration process during sleep. This study explores if IOS parameters, which measure airway resistance and elasticity through small pressure oscillations during normal breathing, correlate with the final titration pressures (CPAP, EPAP, IPAP, and ΔP) determined by polysomnography.
Adult patients diagnosed with moderate-to-severe OSA (Apnea-Hypopnea Index ≥ 15) will undergo standard diagnostic sleep testing followed by IOS testing using the Vyaire Vyntus BodyBox® system. The researchers will evaluate whether these respiratory measurements can accurately predict required airway pressures and if they can help clinicians distinguish between patients who need Continuous Positive Airway Pressure (CPAP) versus Bilevel Positive Airway Pressure (BPAP) therapy.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kadir Burak Akgün, Assistant Professor
- Phone Number: +905448127828
- Email: kadirburakakgun@gmail.com
Study Locations
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Hatay
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Antakya, Hatay, Turkey (Türkiye), 31001
- Hatay Mustafa Kemal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 to 80 years
- Diagnosed with obstructive sleep apnea (OSA) by overnight polysomnography (PSG)
- Apnea-hypopnea index (AHI) ≥ 15
- Undergoing positive airway pressure (PAP) titration (CPAP or BPAP)
- Able to perform impulse oscillometry (IOS) test
- Provided written informed consent
Exclusion Criteria:
- Central sleep apnea
- Neuromuscular disease or restrictive lung disease
- Recent upper airway infection (< 2 weeks)
- Incomplete PSG or IOS data
- Inability to cooperate with testing procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Moderate-to-Severe OSA Patients
Adult patients newly diagnosed with moderate-to-severe obstructive sleep apnea (AHI ≥ 15) who are scheduled to undergo an overnight PAP titration polysomnography.
All participants in this single cohort will receive baseline impulse oscillometry (IOS) testing prior to their sleep study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between baseline impulse oscillometry (IOS) parameters (R5, X5, and Fres) and optimal CPAP pressure.
Time Frame: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks)
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Evaluating the relationship between specific lung function parameters-specifically total airway resistance (R5), reactance (X5), and resonant frequency (Fres)-measured by a daytime IOS session, and the effective Continuous Positive Airway Pressure (CPAP) determined during the subsequent overnight titration study.
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From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discriminative ability of IOS parameters for CPAP versus BPAP treatment allocation.
Time Frame: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
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Assessing whether baseline impulse oscillometry parameters (R5, X5, Fres, AX) can predict if a patient will require Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BPAP) therapy.
This will be evaluated using the Area Under the Receiver Operating Characteristic (ROC) Curve.
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From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
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Correlation between baseline IOS reactance parameters and bilevel pressure settings (IPAP/EPAP).
Time Frame: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
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Assessing whether baseline impulse oscillometry parameters can predict the specific Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure (EPAP) levels required for Bilevel Positive Airway Pressure (BPAP) therapy.
This will be evaluated using the correlation coefficient.
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From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- HMKU-25A002-IOS-PAP
- BAP Project No: 25.A.002 (Other Identifier: Hatay Mustafa Kemal University Scientific Research Projects Coordination Unit)
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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