Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Fondazione Don Gnocchi
RECRUITING
Milan
Contact Information
Primary
Eleonora Volpato, PhD
eleonora.volpato@unicatt.it
3293782692
Backup
Valentina Poletti, MS
valentina.poletti@unicatt.it
3485446235
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-04-07
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Fondazione Don Carlo Gnocchi Onlus

This content was sourced from clinicaltrials.gov