| NCT ID | NCT06664450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2025-05-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-02-03 with a primary completion date of 2025-05-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: This observational, cross-sectional pilot study aims to assess "Brain Fog" (cognitive symptoms impacting memory, attention, and concentration) in severe Obstructive Sleep Apnea (OSA) patients. It compares two groups: those on CPAP treatment for at least 3 months and those not yet treated. Procedures: Severe OSA patients (AHI \> 30) will complete a 30-minute questionnaire at the Sleep Center Clinic, covering sociodemographic information, OSA diagnosis, and treatment details. Assessment scales will measure daytime sleepiness, sleep quality, and psychophysical fatigue. Participants: 80 Sleep Center outpatients, evenly divided by age and gender: 40 with severe OSA on CPAP for at least 3 months. 40 with severe OSA not yet on CPAP. Duration: Approximately 12 months.
Eligibility Criteria
Inclusion Criteria: * Patients with severe OSA treated with CPAP for at least 3 months. * Patients with severe OSA in new access and therefore not yet subjected to CPAP treatment. * Patients with severe OSA who are able to understand the Italian language. Exclusion Criteria: * Patients who do not have a certified diagnosis of severe OSA. * Patients with mild or moderate OSA. * Patients with OSA who are unable to understand the Italian language. * Patients with OSA who have neurological and/or oncological comorbidities, as verified by medical records. * Patients with documented cognitive deficits, as verified by medical records. * Patients with certified diagnoses of psychiatric disorders and/or substance use disorders (SUD), as verified by medical records.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06664450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06664450 currently recruiting?
Yes, NCT06664450 is actively recruiting participants. Contact the research team at eleonora.volpato@unicatt.it for enrollment information.
Where is the NCT06664450 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06664450 clinical trial?
NCT06664450 is sponsored by Fondazione Don Carlo Gnocchi ETS. The trial plans to enroll 80 participants.