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Cognitive Function and Quality of Life in Obstructive Sleep Apnea

25 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

86

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time on the Psychomotor Vigilance Task (PVT)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Working Memory Assessed via Memory Span Test
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

25 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2026

Publicado por primera vez (Actual)

1 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Cognition and QoL in OSA

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .