Evaluating health changes in patients with Obstructive Sleep Apnea after ventilotherapy
Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
This study is testing how three weeks of ventilotherapy affects the health, thinking skills, and overall wellbeing of people with Obstructive Sleep Apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Piancavallo, VCO) |
| Trial ID | NCT06312956 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the health of patients with Obstructive Sleep Apnea Syndrome (OSAS) before and after three weeks of ventilotherapy. It focuses on cognitive performance, blood biomarkers related to neurodegeneration, and psychosocial wellbeing. Patients will undergo neuropsychological assessments, blood sampling, and complete self-reported questionnaires to identify changes in these areas. The study aims to provide comprehensive evidence on the benefits of ventilotherapy, potentially leading to improved patient outcomes and compliance.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Obstructive Sleep Apnea Syndrome who are right-handed.
Not a fit: Patients with previous ventilotherapy, neurological conditions, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive performance and psychosocial wellbeing in patients with Obstructive Sleep Apnea.
How similar studies have performed: While multidisciplinary approaches to OSAS treatment are rare, existing studies suggest potential benefits of ventilotherapy, indicating this approach is promising but not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * OSAS diagnosis (AHI \> 5) * handedness: right Exclusion Criteria: * previous ventilotherapy * neurological and/or neurodegenerative conditions * Personality disorders, autism spectrum disorders, schizophrenia, psychosis * sleep disorders comorbidities (eg., narcolepsy)
Where this trial is running
Piancavallo, VCO
- IRCCS Istituto Auxologico Italiano — Piancavallo, Vco, Italy (Recruiting)
Study contacts
- Study coordinator: Sofia Tagini, PhD
- Email: s.tagini@auxologico.it
- Phone: 00393339915288
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.