Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness

NCT06334601 | Recruiting

• 1 other identifier: 09C333
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Collapsibility of upper airways; Muscle responsiveness

Outcome Measures

Primary Outcomes (2)

• Upper airway collapsibility

  Evaluation during wakefulness

  During the diagnostic test

• Upper airway muscle responsiveness

  Evaluation during wakefulness

  During the diagnostic test

Study Arms (1)

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).

Diagnostic Test: Tests of upper airway collapsibility and muscle responsiveness.

Interventions

Tests of upper airway collapsibility and muscle responsiveness. DIAGNOSTIC_TEST

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

Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano,Ospedale San Luca

Milan, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Elisa Perger, MD

CONTACT

+390261911; e.perger@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 28, 2024
• Study Start: January 15, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)