IOS Parameters and PAP Titration Pressure in Obstructive Sleep Apnea
ConditionObstructive Sleep Apnea (OSA)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMustafa Kemal University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Central sleep apnea
Neuromuscular disease or restrictive lung disease
Recent upper airway infection (< 2 weeks)
Incomplete PSG or IOS data
Trial population
Adults with moderate-to-severe obstructive sleep apnea (OSA) undergoing PAP titration and IOS testing at Hatay Mustafa Kemal University.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
92 Participants
are grouped into 1 trial groupGroup A: Moderate-to-Severe OSA Patients
Trial outcomes
Primary outcomes
1
Correlation between baseline impulse oscillometry (IOS) parameters (R5, X5, and Fres) and optimal CPAP pressure.
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.
Time frame
From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks)Secondary outcomes
1
Discriminative ability of IOS parameters for CPAP versus BPAP treatment allocation.
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.
Time frame
From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).2
Correlation between baseline IOS reactance parameters and bilevel pressure settings (IPAP/EPAP).
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.
Time frame
From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).Sponsors and contacts
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Source ClinicalTrials.gov
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