Impact of Continuous Positive Airway Pressure Treatment on Cognitive Function in Adults With Down Syndrome With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of the changes on cognitive attentional tasks
研究概览
简要总结
Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance.
In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. CPAP treatment, however, is not regularly proposed in adults with DS and OSA. It is usually presumed both by caregivers and physicians, that DS patients will not tolerate or adapt to the treatment, and that they would not benefit much more from CPAP treatment. Therefore, data about the feasibility and impact of CPAP treatment on cognitive function in this population is lacking.
The main objective of this study is to investigate cognitive performance in adults with DS and OSA, the corresponding functional brain changes and their reversibility with CPAP treatment.
详细描述
Population Participants will be included from the Catalan Down Syndrome Foundation (FCSD). After obtaining a written informed consent, approved by the ethical committee, a total of 60 adult subjects of both sexes with SD and without dementia will be included. Forty subjects with a diagnosis of severe OSA (AHI> 30) without significant comorbidities or excessive daytime sleepiness (Epworth <12) and 20 subjects without OSA.
Objectives:
The general objective is to evaluate cognitive and/or behavioural dysfunction in adults with Down syndrome that can improve with CPAP treatment.
- By evaluating sleep, cognitive function and behaviour aspects in adults with Down syndrome with and without OSA.
- By assessing the changes in sleep, in cognitive, behavioural function, and brain connectivity measures after 6 month of treatment in subjects with DS and severe OSA.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sexes with ages over 18 years old with DS.
- •A good general health with adequate visual and auditory acuity will be required
- •Understanding and accepting the study procedures and signing an informed consent (guardian and / or patient).
- •intelligence quotient(IQ) ratio> 34 (mild and moderate severe intellectual disability according to the International Statistical Classification of Diseases and Related Health Problems, ICD-10, criteria).
- •Subjects without dementia: Absence of loss of cognitive functions (demonstrated by the longitudinal administration of neuropsychological tests and verified by family members)
- •Absence of psychiatric comorbidity
排除标准
- •Severe intellectual disability (due to limitations in cognitive tests)
- •Presence of psychiatric pathology, unstable disease, cardiac or respiratory failure.
- •Intake of psychoactive drugs in the three months prior to the study.
- •Patients diagnosed with OSA, undergoing treatment with CPAP.
- •Subjects with an Epworth Sleep Scale score > 12
结局指标
主要结局
Assessment of the changes on cognitive attentional tasks
时间窗: Baseline and after 6 months of treatment
psychomotor speed (in seconds) performing an attentional task
Changes in cerebral functional connectivity
时间窗: Baseline and after 6 months of treatment
Significant probability maps (SPM) showing statistical changes on connectivity measures between sleep stages
次要结局
未报告次要终点