Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness

NCT ID: NCT06334601

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-15

Study Completion Date

2025-12-31

Brief Summary

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In the framework of pathophysiological trait in obstructive sleep apnea (OSA) patients, a simplified method is proposed to measure upper airway (UA) collapsibility and muscle responsiveness during wakefulness.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Obstructive Sleep Apnea

Patients evaluated for sleep disorders, who present an at home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index \>14).

Tests of upper airway collapsibility and muscle responsiveness.

Intervention Type DIAGNOSTIC_TEST

Upper airway collapsibility, upper airway muscle responsiveness and loop gain will be assessed during single study visit.

Polysomnography

Interventions

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Tests of upper airway collapsibility and muscle responsiveness.

Upper airway collapsibility, upper airway muscle responsiveness and loop gain will be assessed during single study visit.

Polysomnography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Obstructive Sleep Apnea (OSA)
* At home-polygraphy with at least one EEG channel (PSG) reporting moderate-to severe obstructive sleep apnea (apnea-hypopnea index \>14).

Exclusion Criteria

* OSA treatment ongoing during two weeks before PSG
* Unstable cardio-respiratory disease in the 3 months before enrollment
* Subjects in O2 treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Auxologico Italiano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Auxologico Italiano,Ospedale San Luca

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elisa Perger, MD

Role: CONTACT

+390261911 ext. 2705

Facility Contacts

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Elisa Perger, MD

Role: primary

+390261911 ext. 2705

Other Identifiers

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09C333

Identifier Type: -

Identifier Source: org_study_id

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