Assessing cognitive symptoms in severe sleep apnea patients
Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study
This study is trying to see if people with severe sleep apnea who have been using CPAP for a while have fewer memory and attention problems compared to those who haven't started treatment yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06664450 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to evaluate 'Brain Fog'—cognitive symptoms affecting memory, attention, and concentration—in patients with severe Obstructive Sleep Apnea (OSA). It compares two groups: those who have been on CPAP treatment for at least 3 months and those who have not yet started treatment. Participants will complete a 30-minute questionnaire at the Sleep Center Clinic, which includes assessments of daytime sleepiness, sleep quality, and psychophysical fatigue. The study will involve 80 outpatients, evenly divided by age and gender, over a duration of approximately 12 months.
Who should consider this trial
Good fit: Ideal candidates are patients with severe OSA who have either been on CPAP for at least 3 months or are newly diagnosed and not yet treated.
Not a fit: Patients with mild or moderate OSA, or those with neurological, oncological, or psychiatric comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive impairments in sleep apnea patients and improve treatment approaches.
How similar studies have performed: While studies on cognitive impairment in sleep apnea exist, this specific observational approach focusing on 'Brain Fog' in a comparative manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, MI
- IRCCS Fondazione Don Gnocchi — Milan, Mi, Italy (Recruiting)
Study contacts
- Study coordinator: Eleonora Volpato, PhD
- Email: eleonora.volpato@unicatt.it
- Phone: 3293782692
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.