Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Continuous Positive Airway Pressure Ventilotherapy.
- Кому может быть актуально
- Состояния в реестре: Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological, Cognitive Impairment. Базовые параметры: 20 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome (OSAS), before and after three weeks of ventilotherapy. Specifically, the study aims to identify pre- vs post-treatment differences in the following domains: * cognitive performance * blood expression of biomarkers related to neurodegeneration * psychosocial wellbeing Thus, patients will complete the following evaluations before (T0) and after (T1) ventilotherapy: * neuropsychological standard assessment * blood sampling * psychosocial self-reported questionnaires
Подробное описание
Obstructive Sleep Apnea Syndrome is associated with cognitive difficulties, low psychosocial wellbeing and quality of life; however, the possible beneficial contribution of ventilotherapy on these dimensions is not completely clear. Ventilotherapy restores brain oxygenation and improve rest, possibly increasing cognitive performances, psychosocial health and quality of life. Multidisciplinary approaches to the treatment of OSAS are rare, although recommended. Solid proof of OSAS comorbidities may encourage clinicians to adopt a holistic perspective of care, leading to better rehabilitative outcomes. Also, evidence of the beneficial effects of ventilotherapy could increase patients' compliance to ventilotherapy, which is generally low.
The study aims to evaluate multiple dimensions of patient's health before and after three weeks of ventilotherapy, focusing on the cognitive performance, the blood expression of biomarkers related to neurodegeneration, and individual's psychosocial wellbeing.
Overall, it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy. Also, a reduction in the blood expression of biomarkers related to neurodegeneration (if found before the treatment) is hypothesized, although the limited research in this field requires cautious predictions.
Comprehensive evidence about OSAS comorbidity, beyond breath and sleep difficulties, is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care. Effective multidisciplinary approaches are considered the gold standard in medical care, leading to better treatment outcomes and higher patients' satisfaction.
Beyond the clear ethical implication of providing higher quality of treatment, multidisciplinary interventions also imply a shared responsibility of treatment, preventing from clinical misjudgments and professionals' burnout.
Вмешательства
- Устройство Continuous Positive Airway Pressure Ventilotherapy
Breathing support device during sleeping
Первичные конечные точки
- Overall cognitive functioning [Срок оценки: baseline and after 3 weeks]
- Selective attention [Срок оценки: baseline and after 3 weeks]
- Memory and learning [Срок оценки: baseline and after 3 weeks]
- Visuo-spatial abilities [Срок оценки: baseline and after 3 weeks]
- Inhibition [Срок оценки: baseline and after 3 weeks]
- Planning [Срок оценки: baseline and after 3 weeks]
- Decision making [Срок оценки: baseline and after 3 weeks]
Вторичные конечные точки (3)
- biomarkers of neurodegeneration [Срок оценки: baseline and after 3 weeks]
- psychosocial wellbeing and satisfaction [Срок оценки: baseline and after 3 weeks]
- Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction) [Срок оценки: baseline and after 3 weeks]
Критерии участия
Критерии включения
- OSAS diagnosis (AHI > 5)
- handedness: right
Критерии исключения
- previous ventilotherapy
- neurological and/or neurodegenerative conditions
- Personality disorders, autism spectrum disorders, schizophrenia, psychosis
- sleep disorders comorbidities (eg., narcolepsy)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Италия · 1 центр
- IRCCS Istituto Auxologico Italiano — Piancavallo
Идентификаторы
NCT: NCT06312956 · 21C403