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临床试验/NCT07678918
NCT07678918尚未招募不适用

Correlation Between the Cognitive Function and Quality of Life in Patients With OSA

Assiut University0 个研究点目标入组 86 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
86
主要终点
Time on the Psychomotor Vigilance Task (PVT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Time on the Psychomotor Vigilance Task (PVT)

时间窗: 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

次要结局

  • Working Memory Assessed via Memory Span Test(Within 10 days following the diagnostic polysomnography (PSG))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Hosni Mostafa Shaker

Resident at Chest Diseases & Tuberculosis Department, Assiut University

Assiut University

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