Cognitive Function and Quality of Life in Obstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
86 Participants
are grouped into 2 trial groupsGroup A: Patients Group (OSA)
Group B: Control Group
Trial outcomes
Primary outcomes
1
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
Time frame
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
Time frame
Within 10 days following the diagnostic polysomnography (PSG)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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