Brain Fog in Sleep Apnea
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Patients with severe OSA treated with CPAP for at least 3 months.
Group B: Patients with severe OSA in new access and therefore not yet subjected to CPAP treatment.
Trial outcomes
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.
Time frame
At enrollment onlySecondary outcomes
1
Epworth Sleepiness Scale (ESS)
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.
Time frame
At enrollment only2
Pittsburgh Sleep Quality Index (PSQI)
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
Time frame
At enrollment only3
Fatigue Severity Scale (FSS)
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.
Time frame
At enrollment onlySponsors and contacts
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Source ClinicalTrials.gov