Clinical trial NCT06664450: Brain Fog in Sleep Apnea
Official title: Exploring Brain Fog Symptoms in Patients with Obstructive Sleep Apnea and CPAP Therapy Impact: a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea (OSA)
Brain Fog
Cognitive Impairment
CPAP Therapy
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Brain Fog
timeFrame: At enrollment only
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: At enrollment only
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At enrollment only
measure: Fatigue Severity Scale (FSS)
timeFrame: At enrollment only
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Fondazione Don Gnocchi
state: MI
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.