NCT07554430

Brief 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). 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.

Trial Health

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Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jan 2027

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

obstructive sleep apneapositive airway pressurecpapbpap

Outcome Measures

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.

    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.

    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).

    From baseline IOS measurement to completion of the overnight titration study (assessed up to 4 weeks).

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with moderate-to-severe obstructive sleep apnea (OSA) undergoing PAP titration and IOS testing at Hatay Mustafa Kemal University.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Antakya, Hatay, 31001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMicrocephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kadir Burak Akgün, Assistant Professor

CONTACT

+905448127828kadirburakakgun@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 2, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Locations

TU(1)