Diurnal Evaluation of OSA Upper Airway Collapsibility and Muscle Responsiveness (Muscle-OSA)

March 25, 2024 updated by: Istituto Auxologico Italiano

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milano, Italy, 20145
        • Recruiting
        • IRCCS Istituto Auxologico Italiano,Ospedale San Luca
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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

Polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper airway collapsibility
Time Frame: During the diagnostic test
Evaluation during wakefulness
During the diagnostic test
Upper airway muscle responsiveness
Time Frame: During the diagnostic test
Evaluation during wakefulness
During the diagnostic test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Tests of upper airway collapsibility and muscle responsiveness.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe