Obstructive Sleep ApneaNCT07678918
Cognitive Function and Quality of Life in Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea and Cognitive Impairment, run by Assiut University.
Trial summary
Obstructive Sleep Apnea (OSA) is a common condition that disrupts normal breathing during sleep. Beyond causing daytime tiredness, OSA can also impact a person's cognitive functions, such as their attention span, memory, and problem-solving skills, which may in turn affect their overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Cognitive Impairment, Quality of Life
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2027
- 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
- Adult, Older adult
Study population: The study population comprises two groups: an adult patient group and a healthy control group. The patient group includes individuals over 18 years of age who meet the AASM diagnostic criteria for Obstructive Sleep Apnea (OSA) and are attending the Sleep Medicine Unit at Assiut University Hospital for diagnostic polysomnography. The control group consists of healthy community members related to the patients. These controls are matched for age, sex, education level, social status, and comorbidities, and must have a low risk of undiagnosed OSA as verified by the STOP-BANG questionnaire.
Who may be able to join
- Patients Group: Age > 18 years.
- Patients Group: Meeting the AASM diagnostic criteria for OSA.
- Control Group: Age and sex-matched community members related to the patients.
- Control Group: Education level, social status, and comorbidity-matched people.
Who cannot join
- Patients Group: OSA patients who are compliant on PAP therapy (> 4 hours, > 5 nights/week) for ≥ 6 months.
- Patients Group: Inability to comprehend and/or co-operate with the instructions provided by the investigators during neurocognitive function assessment.
- Patients Group: History of neurological comorbidities with potential cognitive impairment (previous cerebrovascular stroke, dementia).
- Patients Group: Patients who are maintained on medications that potentially impair cognitive performance (histamine receptor antagonist, antipsychotic, antidepressant, or mood stabilizer drugs).
- Patients Group: Use of alcohol, or illicit drugs that interfere with cognitive function (cannabis, opioids, amphetamine or equivalents).
- Control Group: Intermediate or high-risk of having undiagnosed OSA as assessed by the STOP-BANG questionnaire.
About this study
Official title: Correlation Between the Cognitive Function and Quality of Life in Patients With OSA
Obstructive Sleep Apnea (OSA) is a common condition that disrupts normal breathing during sleep. Beyond causing daytime tiredness, OSA can also impact a person's cognitive functions, such as their attention span, memory, and problem-solving skills, which may in turn affect their overall quality of life.
The main purpose of this study is to compare the thinking and memory skills of adults recently diagnosed with OSA against a control group of healthy adults without the condition. Furthermore, the researchers aim to understand how specific cognitive challenges (like difficulty sustaining attention) relate to a patient's physical and mental well-being.
Participants in the study will undergo an overnight sleep test (diagnostic polysomnography) at a sleep clinic. Shortly after the sleep test, participants will complete a series of short, computer-based tasks designed to measure their attention, memory, and executive function. They will also be asked to fill out standard questionnaires regarding their daily sleepiness, mood, and health-related quality of life.
Read the detailed description
Obstructive sleep apnea (OSA) is a serious health condition affecting 9-36% of the global population, associated with significant systemic morbidity that profoundly impacts general health and quality of life (QoL) beyond the immediate symptoms of sleep disruption. Among the serious repercussions of OSA is neurocognitive impairment, which extends beyond impaired attention to include deficits in memory, executive functions, and visuo-constructive performance. Various pathophysiological links between OSA and cognitive impairment have been proposed, including sleep fragmentation, intermittent hypoxia, and apnea-related cerebral hypoperfusion.
Although OSA has been linked to poorer health-related QoL, fewer studies have investigated cognitive impairment as a factor that potentially explains this diminished QoL. This study aims to comprehensively compare the cognitive performance of patients with OSA to that of matched healthy controls, and to verify the correlation between health-related QoL (derived from the SF-36) and multiple domains of neurocognitive function.
Participants enrolled in the study will undergo a series of structured evaluations:
- Clinical \& Socio-economic Evaluation: A structured interview will capture clinical data including sleep symptoms, comorbidities, and medication use. Anthropometric measurements (BMI, neck, and waist circumferences) will be taken, and excessive daytime sleepiness will be assessed using the Epworth Sleepiness Scale. Baseline cardiopulmonary status will be evaluated via pulmonary function testing (spirometry), radiological assessment (Chest X-Ray and Transthoracic Echocardiography), and routine laboratory tests (CBC, ABG, electrolytes, thyroid function, and lipid profile).
- Diagnostic Polysomnography (PSG):All participants will undergo a full-night, supervised, in-laboratory diagnostic PSG at the Sleep Medicine Unit. Physiological parameters will be continuously monitored to score sleep stages and respiratory events, allowing researchers to accurately classify OSA severity based on the Apnea-Hypopnea Index (AHI).
- Cognitive Function Assessment: Within 10 days of the diagnostic PSG, participants will complete a computerized neurocognitive test battery using the Psychology Experiment Building Language (PEBL) software. The assessment will evaluate specific cognitive domains using the following tools:
- Attention: Assessed via a 10-Minute Psychomotor Vigilance Task (PVT) for sustained attention, and a Four-choice Test for selective attention.
- Memory: Assessed via a Memory Span Test targeting working memory, short-term memory, and visual processing.
- Executive Function: Assessed via the Wisconsin's Card Sorting Test to evaluate mental flexibility, problem-solving, and abstraction-reasoning.
- Quality of Life and Psychological Assessment: Participants will complete standardized questionnaires to evaluate their overall well-being and mood. These include the Short Form-36 Health Survey (SF-36) for general QoL, the Calgary Sleep Apnea Quality of Life Index (SAQLI) for disease-specific QoL, and the Beck Depression Inventory (BDI) to explore the potential impact of depressive symptoms on cognitive function and QoL.
- Keywords
- Obstructive Sleep Apnea, Cognitive Function, Quality of Life, Neurocognitive Impairment, Psychomotor Vigilance, Polysomnography, SF-36
- Medical subject headings
- Sleep Apnea, Obstructive, 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 Group (OSA) | Patients aged > 18 years meeting the AASM diagnostic criteria for obstructive sleep apnea (OSA) who are attending the Sleep Medicine Unit for diagnostic polysomnography (PSG). | |
| Control Group | Healthy community members matched to the patient group by age, sex, education level, social status, and comorbidities, who do not have an intermediate or high risk of undiagnosed OSA as assessed by the STOP-BANG questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time on the Psychomotor Vigilance Task (PVT)
The mean reaction time, reported in milliseconds, for the total number of trials over the 10-minute Psychomotor Vigilance Task (PVT) to evaluate sustained attention
Measured: Within 10 days following the diagnostic polysomnography (PSG)
Secondary outcomes (1)
Working Memory Assessed via Memory Span Test
The memory span, measured in seconds, evaluated using the computerized Memory Span Test to assess working memory, short-term memory, and visual processing
Measured: Within 10 days following the diagnostic polysomnography (PSG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hosni Mostafa Shaker, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678918
- Sponsor's protocol ID
- Cognition and QoL in OSA
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Cognitive Function and Quality of Life in Patients With OSA
- ClinicalTrials.gov ID
- NCT07678918
- Acronym / sponsor ID
- Cognition and QoL in OSA
- Keywords
- Obstructive Sleep Apnea, Cognitive Function, Quality of Life, Neurocognitive Impairment, Psychomotor Vigilance, Polysomnography, SF-36
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Jul 2026 (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.
Obstructive Sleep Apnea (OSA) is a common condition that disrupts normal breathing during sleep. Beyond causing daytime tiredness, OSA can also impact a person's cognitive functions, such as their attention span, memory, and problem-solving skills, which may in turn affect their overall quality of life.
The main purpose of this study is to compare the thinking and memory skills of adults recently diagnosed with OSA against a control group of healthy adults without the condition. Furthermore, the researchers aim to understand how specific cognitive challenges (like difficulty sustaining attention) relate to a patient's physical and mental well-being.
Participants in the study will undergo an overnight sleep test (diagnostic polysomnography) at a sleep clinic. Shortly after the sleep test, participants will complete a series of short, computer-based tasks designed to measure their attention, memory, and executive function. They will also be asked to fill out standard questionnaires regarding their daily sleepiness, mood, and health-related quality of life.
Detailed description
Obstructive sleep apnea (OSA) is a serious health condition affecting 9-36% of the global population, associated with significant systemic morbidity that profoundly impacts general health and quality of life (QoL) beyond the immediate symptoms of sleep disruption. Among the serious repercussions of OSA is neurocognitive impairment, which extends beyond impaired attention to include deficits in memory, executive functions, and visuo-constructive performance. Various pathophysiological links between OSA and cognitive impairment have been proposed, including sleep fragmentation, intermittent hypoxia, and apnea-related cerebral hypoperfusion.
Although OSA has been linked to poorer health-related QoL, fewer studies have investigated cognitive impairment as a factor that potentially explains this diminished QoL. This study aims to comprehensively compare the cognitive performance of patients with OSA to that of matched healthy controls, and to verify the correlation between health-related QoL (derived from the SF-36) and multiple domains of neurocognitive function.
Participants enrolled in the study will undergo a series of structured evaluations:
- Clinical \& Socio-economic Evaluation: A structured interview will capture clinical data including sleep symptoms, comorbidities, and medication use. Anthropometric measurements (BMI, neck, and waist circumferences) will be taken, and excessive daytime sleepiness will be assessed using the Epworth Sleepiness Scale. Baseline cardiopulmonary status will be evaluated via pulmonary function testing (spirometry), radiological assessment (Chest X-Ray and Transthoracic Echocardiography), and routine laboratory tests (CBC, ABG, electrolytes, thyroid function, and lipid profile).
- Diagnostic Polysomnography (PSG):All participants will undergo a full-night, supervised, in-laboratory diagnostic PSG at the Sleep Medicine Unit. Physiological parameters will be continuously monitored to score sleep stages and respiratory events, allowing researchers to accurately classify OSA severity based on the Apnea-Hypopnea Index (AHI).
- Cognitive Function Assessment: Within 10 days of the diagnostic PSG, participants will complete a computerized neurocognitive test battery using the Psychology Experiment Building Language (PEBL) software. The assessment will evaluate specific cognitive domains using the following tools:
- Attention: Assessed via a 10-Minute Psychomotor Vigilance Task (PVT) for sustained attention, and a Four-choice Test for selective attention.
- Memory: Assessed via a Memory Span Test targeting working memory, short-term memory, and visual processing.
- Executive Function: Assessed via the Wisconsin's Card Sorting Test to evaluate mental flexibility, problem-solving, and abstraction-reasoning.
- Quality of Life and Psychological Assessment: Participants will complete standardized questionnaires to evaluate their overall well-being and mood. These include the Short Form-36 Health Survey (SF-36) for general QoL, the Calgary Sleep Apnea Quality of Life Index (SAQLI) for disease-specific QoL, and the Beck Depression Inventory (BDI) to explore the potential impact of depressive symptoms on cognitive function and QoL.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Group (OSA) | – | –Patients aged > 18 years meeting the AASM diagnostic criteria for obstructive sleep apnea (OSA) who are attending the Sleep Medicine Unit for diagnostic polysomnography (PSG). |
| Control Group | – | –Healthy community members matched to the patient group by age, sex, education level, social status, and comorbidities, who do not have an intermediate or high risk of undiagnosed OSA as assessed by the STOP-BANG questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population comprises two groups: an adult patient group and a healthy control group. The patient group includes individuals over 18 years of age who meet the AASM diagnostic criteria for Obstructive Sleep Apnea (OSA) and are attending the Sleep Medicine Unit at Assiut University Hospital for diagnostic polysomnography. The control group consists of healthy community members related to the patients. These controls are matched for age, sex, education level, social status, and comorbidities, and must have a low risk of undiagnosed OSA as verified by the STOP-BANG questionnaire.
Key inclusion criteria (4 listed)
- Patients Group: Age > 18 years.
- Patients Group: Meeting the AASM diagnostic criteria for OSA.
- Control Group: Age and sex-matched community members related to the patients.
- Control Group: Education level, social status, and comorbidity-matched people.
Key exclusion criteria (6 listed)
- Patients Group: OSA patients who are compliant on PAP therapy (> 4 hours, > 5 nights/week) for ≥ 6 months.
- Patients Group: Inability to comprehend and/or co-operate with the instructions provided by the investigators during neurocognitive function assessment.
- Patients Group: History of neurological comorbidities with potential cognitive impairment (previous cerebrovascular stroke, dementia).
- Patients Group: Patients who are maintained on medications that potentially impair cognitive performance (histamine receptor antagonist, antipsychotic, antidepressant, or mood stabilizer drugs).
- Patients Group: Use of alcohol, or illicit drugs that interfere with cognitive function (cannabis, opioids, amphetamine or equivalents).
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
Time on the Psychomotor Vigilance Task (PVT)
Time frame: Within 10 days following the diagnostic polysomnography (PSG)
The mean reaction time, reported in milliseconds, for the total number of trials over the 10-minute Psychomotor Vigilance Task (PVT) to evaluate sustained attention
1 secondary outcome
Working Memory Assessed via Memory Span Test
Time frame: Within 10 days following the diagnostic polysomnography (PSG)
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 1 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Cognitive Impairment, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time on the Psychomotor Vigilance Task (PVT) (time frame: Within 10 days following the diagnostic polysomnography (PSG)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.