Assessing cognitive symptoms in severe sleep apnea patients
Official title: Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study
Run by Fondazione Don Carlo Gnocchi ETS · NCT06664450 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione Don Carlo Gnocchi ETS Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | February 3, 2025 |
| Main results expected | May 3, 2025 |
| Study ends | April 7, 2026 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT06664450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with mild or moderate OSA, or those with neurological, oncological, or psychiatric comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While studies on cognitive impairment in sleep apnea exist, this specific observational approach focusing on 'Brain Fog' in a comparative manner is relatively novel.
Who can join: the full rules
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 it's running
-
IRCCS Fondazione Don Gnocchi
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Eleonora Volpato, PhD
- Email: eleonora.volpato@unicatt.it
- Phone: 3293782692
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography
Researchers are testing a smart-mattress-based method that uses SpO2 and ballistocardiography data to predict sleep apnea severity in adults undergoing overnight sleep study.
-
Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea
This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.
-
Functional capacity and muscle function in adults with obstructive sleep apnea
This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.
-
Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea
This study tests whether applying gentle electrical stimulation to the throat muscles at night can reduce sleep apnea severity in adults with obstructive sleep apnea.
-
Physical activity habits and sleep/ breathing in obstructive sleep apnea
This study tests whether daily physical activity habits affect sleep quality and breathing measurements in people with obstructive sleep apnea who are on CPAP therapy.
-
CES-EES score and a wearable ring for diagnosing obstructive sleep apnea
This study tests whether the CES-EES clinical score and the Belun Ring wearable can accurately diagnose obstructive sleep apnea without in-lab polysomnography in adults referred for suspected OSA.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.