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Cognitive Function and Quality of Life in Obstructive Sleep Apnea

2026年6月25日 更新者:Amira Hosni Mostafa Shaker、Assiut University

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

86

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

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.

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time on the Psychomotor Vigilance Task (PVT)
大体时间: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
Within 10 days following the diagnostic polysomnography (PSG)

次要结果测量

结果测量
措施说明
大体时间
Working Memory Assessed via Memory Span Test
大体时间:Within 10 days following the diagnostic polysomnography (PSG)
The memory span, measured in seconds, evaluated using the computerized Memory Span Test to assess working memory, short-term memory, and visual processing
Within 10 days following the diagnostic polysomnography (PSG)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年6月25日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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