Actively Recruiting

Age: 18Years +
All Genders
NCT06664450

Brain Fog in Sleep Apnea

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-08-24

80

Participants Needed

1

Research Sites

61 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Brain Fog in Sleep Apnea

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe OSA treated with CPAP for at least 3 months.
  • Patients with severe OSA who are new and have not yet started CPAP treatment.
  • Patients with severe OSA who can understand the Italian language.
Not Eligible

You will not qualify if you...

  • Patients without a certified diagnosis of severe OSA.
  • Patients with mild or moderate OSA.
  • Patients unable to understand the Italian language.
  • Patients with neurological or oncological comorbidities.
  • Patients with documented cognitive deficits.
  • Patients with psychiatric disorders or substance use disorders.

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Fondazione Don Gnocchi

Milan, MI, Italy, 20148

Actively Recruiting

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Research Team

E

Eleonora Volpato, PhD

CONTACT

V

Valentina Poletti, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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