Obstructive Sleep Apnea (OSA)IOS-PAPNCT07554430
IOS Parameters and PAP Titration Pressure in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea (OSA), run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 2 Jan 2027
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with moderate-to-severe obstructive sleep apnea (OSA) undergoing PAP titration and IOS testing at Hatay Mustafa Kemal University.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University
Antakya, Hatay, 31001
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- obstructive sleep apnea, positive airway pressure, cpap, bpap
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks)
Secondary outcomes (2)
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.
Measured: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
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.
Measured: From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- 92 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Burak Akgün, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554430
- Sponsor's protocol ID
- HMKU-25A002-IOS-PAP
- Other IDs
- BAP Project No: 25.A.002
- Acronym
- IOS-PAP
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impulse Oscillometry for Prediction of PAP Titration Pressure in Obstructive Sleep Apnea (IOS-PAP Study)
- ClinicalTrials.gov ID
- NCT07554430
- Acronym / sponsor ID
- IOS-PAP / HMKU-25A002-IOS-PAP
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- obstructive sleep apnea, positive airway pressure, cpap, bpap
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 28 Apr 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with moderate-to-severe obstructive sleep apnea (OSA) undergoing PAP titration and IOS testing at Hatay Mustafa Kemal University.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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.
2 secondary outcomes
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 (OSA), run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 6 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: opening soon, as of the sponsor's last update on 28 Apr 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kadir Burak Akgün, Assistant Professor (+905448127828, kadirburakakgun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 28 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.