Ireland
--:--IST
Recruiting Observational

Brain Fog in Sleep Apnea

NCT06664450 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-02-03
Last updated
2025-08-24

Condition(s) studied

Obstructive Sleep Apnea

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Brain Fog — At enrollment only
    The Italian validation questionnaire is currently undergoing validation by our research group. In the original self-report scale, for each item, respondents are asked to indicate on a 5-point Likert scale (0 = "never", 1 = "rarely", 2 = "occasionally", 3 = "a lot of the time", 4 = "nearly all the time") how often they have experienced each symptom during the last two weeks. Total scale scores range from 0 to 92, with higher scores indicating increased levels of brain fog.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione Don Gnocchi Milan MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664450 on ClinicalTrials.gov ↗ ← All trials in Italy