Obstructive Sleep ApneaBF -OSANCT06664450
Brain Fog in Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2025to 7 Apr 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Don Gnocchi
Milan, MI, 20148
Valentina Poletti, 3485446235, valentinapoletti26496@gmail.com
About this study
Official title: Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea (OSA), Brain Fog, Cognitive Impairment, CPAP Therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Mental Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment only
Secondary outcomes (3)
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
- = Slight chance of dozing
- = Moderate chance of dozing
- = 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.
Measured: At enrollment only
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
Measured: At enrollment only
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:
- = Strongly Disagree
- = Disagree
- = Somewhat Disagree
- = Neutral
- = Somewhat Agree
- = Agree
- = 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.
Measured: At enrollment only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start3 Feb 2025
- Primary completion3 May 2025
- Study completion7 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664450
- Sponsor's protocol ID
- BF-OSA
- Acronym
- BF -OSA
- Status last verified
- Aug 2025
- First submitted
- 28 Oct 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collection will also be conducted by Dr. Valentina Poletti, a member of my research group, who is pursuing her PhD on the same topic.
Publications
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.
PubMed 27242272Rosenberg 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.
PubMed 38217475McWhirter 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.
PubMed 36600580
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Brain Fog Symptoms in Patients With Obstructive Sleep Apnea and CPAP Therapy Impact: A Pilot Study
- ClinicalTrials.gov ID
- NCT06664450
- Acronym / sponsor ID
- BF -OSA / BF-OSA
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea (OSA), Brain Fog, Cognitive Impairment, CPAP Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 May 2025 (actual)
- Study completion
- 7 Apr 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain Fog
Time frame: 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.
3 secondary outcomes
Epworth Sleepiness Scale (ESS)
Time frame: At enrollment only
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At enrollment only
Fatigue Severity Scale (FSS)
Time frame: At enrollment only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 27242272Batool-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.
- Results publication: PubMed 38217475Rosenberg 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.
- Results publication: PubMed 36600580McWhirter 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.
- Individual participant dataSharing planned: No. The data collection will also be conducted by Dr. Valentina Poletti, a member of my research group, who is pursuing her PhD on the same topic.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Volpato, PhD (3293782692, eleonora.volpato@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Fog (time frame: At enrollment only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.