Brain Fog in Sleep Apnea

NCT06664450 | Recruiting DMC

• 1 other identifier: BF-OSA
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea (OSA); Brain Fog; Cognitive Impairment; CPAP Therapy

Outcome Measures

Primary Outcomes (1)

• Brain Fog

  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.

  At enrollment only

Secondary Outcomes (3)

• Epworth Sleepiness Scale (ESS)

  At enrollment only

• Pittsburgh Sleep Quality Index (PSQI)

  At enrollment only

• Fatigue Severity Scale (FSS)

  At enrollment only

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants will be selected from a population of patients with severe Obstructive Sleep Apnea (OSA). Specifically, the population will include two distinct groups: Patients with Severe OSA Treated with CPAP: This group will consist of individuals who have been diagnosed with severe OSA and have been undergoing treatment with Continuous Positive Airway Pressure (CPAP) for at least three months. These patients are expected to have experienced a stabilization in their condition due to adherence to the CPAP therapy. Patients with Severe OSA in New Access: This group will include individuals who are newly diagnosed with severe OSA and have not yet started any treatment with CPAP. These patients will represent a baseline group to compare against those already receiving CPAP treatment. Both groups will consist of adult patients who are able to understand the Italian language, ensuring that they can accurately complete the self-report questionnaires involved in the study. Exclus

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Gnocchi

Milan, MI, 20148, Italy

RECRUITING

Related Publications (3)

• Batool-Anwar S, Goodwin JL, Kushida CA, Walsh JA, Simon RD, Nichols DA, Quan SF. Impact of continuous positive airway pressure (CPAP) on quality of life in patients with obstructive sleep apnea (OSA). J Sleep Res. 2016 Dec;25(6):731-738. doi: 10.1111/jsr.12430. Epub 2016 May 30.

  PMID: 27242272 RESULT

• Rosenberg R, Thorpy MJ, Doghramji K, Morse AM. Brain fog in central disorders of hypersomnolence: a review. J Clin Sleep Med. 2024 Apr 1;20(4):643-651. doi: 10.5664/jcsm.11014.

  PMID: 38217475 RESULT

• McWhirter L, Smyth H, Hoeritzauer I, Couturier A, Stone J, Carson AJ. What is brain fog? J Neurol Neurosurg Psychiatry. 2023 Apr;94(4):321-325. doi: 10.1136/jnnp-2022-329683. Epub 2022 Dec 6.

  PMID: 36600580 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Mental Fatigue; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Eleonora Volpato, PhD

CONTACT

3293782692; eleonora.volpato@unicatt.it

Valentina Poletti, MS

CONTACT

3485446235; valentina.poletti@unicatt.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: February 3, 2025
• Primary Completion: May 3, 2025
• Study Completion: April 7, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)