Evaluating upper airway collapsibility and muscle responsiveness in sleep apnea patients
Diurnal Evaluation of Obstructive Sleep Apnea (OSA) Upper Airway Collapsibility and Muscle Responsiveness
This study is trying to see how well the upper airway holds up and how responsive the muscles are in people with obstructive sleep apnea while they are awake, to help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06334601 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the collapsibility of the upper airway and the responsiveness of muscles in patients with obstructive sleep apnea (OSA) during wakefulness. It utilizes a simplified method to measure these traits, which could enhance understanding of the pathophysiology of OSA. Participants will undergo tests to evaluate their upper airway characteristics based on specific inclusion criteria related to their sleep apnea severity. The study is designed to gather data that may inform future treatment strategies for OSA.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with moderate to severe obstructive sleep apnea as indicated by their apnea-hypopnea index.
Not a fit: Patients currently undergoing treatment for OSA or those with unstable cardio-respiratory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment approaches for patients with obstructive sleep apnea.
How similar studies have performed: While this approach is focused on a specific aspect of OSA, similar studies have shown promise in understanding airway dynamics, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- IRCCS Istituto Auxologico Italiano,Ospedale San Luca — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Elisa Perger, MD
- Email: e.perger@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.