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NCT06334601 Clinical Trial

Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness

Obstructive Sleep Apnea Clinical Trial

— Muscle-OSA  

Official title:
Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06334601
Other study ID # 09C333
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2024
Source Istituto Auxologico Italiano
Contact Elisa Perger, MD
Phone +390261911
Email e.perger@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 66
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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

Locations
Country Name City State
Italy IRCCS Istituto Auxologico Italiano,Ospedale San Luca Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Upper airway collapsibility Evaluation during wakefulness During the diagnostic test
Primary Upper airway muscle responsiveness Evaluation during wakefulness During the diagnostic test
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