Brain Fog in Sleep Apnea

Not yet recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06664450
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

This observational, cross-sectional, single-center pilot study aims to examine the presence of "Brain Fog" - a cluster of cognitive symptoms impairing memory, attention, and concentration - in patients with severe Obstructive Sleep Apnea Syndrome (OSA). It compares two groups: patients who have been undergoing CPAP treatment for at least 3 months and patients who have not yet begun treatment. Patients with severe OSA (AHI \> 30), evaluated by a pulmonologist for CPAP therapy adaptation or already in therapy for at least 3 months, will be invited to participate in the study at the Sleep Center Clinic. After reviewing and signing informed consent, participants will receive a link to access the Qualtrics platform, where they will complete the online self-report questionnaire under the supervision of trained staff, available to assist if needed. The questionnaire, taking approximately 30 minutes to complete, will be administered once and will collect sociodemographic data (gender, age, marital status, educational level, occupational status, comorbidities, diagnosis date, CPAP adaptation start date, and COVID-19 health status over the past 12 months), including the Brain Fog Scale, currently undergoing Italian validation by our Research Group. Additional measures will include the Epworth Sleepiness Scale (ESS) to assess daytime sleepiness, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, the Fatigue Severity Scale (FSS), and Pichot's Fatigue Scale for psychophysical fatigue. The study anticipates recruiting 80 outpatients with severe OSA, evenly divided by age and gender into two groups: 40 patients on CPAP for at least 3 months and 40 patients who have not yet started CPAP. As no prior studies have investigated Brain Fog in OSA patients, conventional power calculations could not be applied; hence, 40 patients per group were deemed sufficient to provide preliminary estimates and identify any logistical or methodological issues for larger studies. Statistical analyses will be conducted using Jamovi 2.5.3 software, encompassing descriptive statistics, independent sample T-tests, Pearson's correlation to measure the strength of linear relationships between Brain Fog and other assessment scale scores, and a multiple regression model to examine the effect of independent variables on Brain Fog. In cases of non-normal data distribution, appropriate non-parametric analyses will be applied. The Brain Fog Scale, currently under Italian validation, may affect the reliability and validity of findings. Significant differences in Brain Fog levels are expected between CPAP-treated and untreated patients, with the hypothesis that treated patients will show symptom reduction. CPAP treatment is anticipated to improve memory, attention, concentration, and mental clarity in severe OSA patients. The collected data may also reveal a positive correlation between CPAP use, sleep quality improvement, and reduced Brain Fog symptoms. Furthermore, this study aims to provide preliminary data for calculating the necessary sample size for larger, more rigorous future studies. Clinical implications suggest that CPAP treatment may not only relieve respiratory symptoms of OSA but also offer significant benefits for cognitive functions, thus enhancing the quality of life for patients with severe OSA.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-29
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Study Start: 2024-11-04
• Primary Completion: 2025-02-03
• Study Completion: 2025-04-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	At enrollment only	self-report questionnaire designed to assess an individual's level of daytime sleepiness. It consists of eight questions that ask respondents to rate their likelihood of dozing off or falling asleep in various everyday situations, such as watching television, sitting in a car, or resting in the afternoon. Each item is scored on a scale from 0 to 3, where: 0 = Would never doze; 1. = Slight chance of dozing; 2. = Moderate chance of dozing; 3. = High chance of dozing The total score is calculated by summing the points from all eight questions, resulting in a possible score range from 0 to 24. Higher scores indicate greater levels of daytime sleepiness.
Pittsburgh Sleep Quality Index (PSQI)	At enrollment only	The Pittsburgh Sleep Quality Index (PSQI) is a standardized self-report questionnaire designed to assess sleep quality and disturbances over a one-month time period. It consists of 19 items that generate a global score based on seven component scores: Subjective Sleep Quality: Assesses the individual's perception of sleep quality.; Sleep Latency: Measures the time taken to fall asleep. Sleep Duration: Evaluates the total amount of sleep obtained. Habitual Sleep Efficiency: Calculates the ratio of total sleep time to time spent in bed.; Sleep Disturbances: Identifies problems that may disrupt sleep, such as waking up during the night.; Use of Sleeping Medications: Assesses the frequency of sleep medication usage. Daytime Dysfunction: Evaluates the impact of sleep quality on daytime functioning.; Each component is scored on a scale of 0 to 3, with higher scores indicating worse sleep quality. The global PSQI score ranges from 0 to 21, where a score greater than 5 is indicative of poor slee
Fatigue Severity Scale (FSS)	At enrollment only	It is a self-report questionnaire designed to assess the severity of fatigue and its impact on daily functioning. It consists of nine statements related to fatigue, and respondents rate their level of agreement with each statement on a scale from 1 to 7, where: 1. = Strongly Disagree; 2. = Disagree; 3. = Somewhat Disagree; 4. = Neutral; 5. = Somewhat Agree; 6. = Agree; 7. = Strongly Agree The statements focus on various aspects of fatigue, including how fatigue interferes with activities, its impact on motivation and physical performance, and the overall experience of fatigue in daily life. The total score is obtained by summing the ratings for all nine items, resulting in a possible score range from 9 to 63, with higher scores indicating greater fatigue severity.