Brain Fog in Sleep Apnea
Key facts
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Where
- Milan, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 3 Feb 2025
- Planned end
- 7 Apr 2026
- Type of study
- Observational, 2 groups
- Record updated
- 24 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients with certified diagnoses of psychiatric disorders and/or substance use disorders (SUD), as verified by medical records
- 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
Where in Italy
- IRCCS Fondazione Don GnocchiMilan, ItalyContact: Valentina PolettiTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Patients with severe OSA treated with CPAP for at least 3 months.
The group consists of patients diagnosed with severe Obstructive Sleep Apnea (OSA) who have been treated with Continuous Positive Airway Pressure (CPAP) therapy for a minimum of 3 months.
- Patients with severe OSA in new access and therefore not yet subjected to CPAP treatment.
This group comprises patients recently diagnosed with severe Obstructive Sleep Apnea (OSA) who have not yet started treatment with Continuous Positive Airway Pressure (CPAP). This cohort will be compared to a group of patients who have been undergoing CPAP therapy for at least 3 months. The primary objective is to assess the presence and severity of cognitive symptoms, commonly referred to as "Brain Fog," which includes impairments in memory, attention, and concentration. Participants in this group will complete a one-time assessment, which will involve various scales to evaluate cognitive function, sleep quality, daytime sleepiness, and fatigue levels. This study aims to provide insights into the cognitive impacts of untreated severe OSA, thereby highlighting the potential benefits of initiating CPAP therapy.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study
- Record updated
- 24 August 2025