Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorFondazione Don Carlo Gnocchi ETS
Academic / other
Locations1 site (Milan, MI)
StatusRecruiting
StartedFebruary 3, 2025
Main results expectedMay 3, 2025
Study endsApril 7, 2026
Registry record updatedAugust 24, 2025
Trial IDNCT06664450 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.