Obstructive Sleep Apnea Clinical Trial
— Muscle-OSAOfficial title:
Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Istituto Auxologico Italiano,Ospedale San Luca | Milano |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Auxologico Italiano |
Italy,
| 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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