Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- sleep patterns of the study population
研究概览
简要总结
The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.
详细描述
The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mothers-caregivers of children and adolescents with DMD
- •Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome)
排除标准
- •Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
- •Working mothers of nocturnal period
结局指标
主要结局
sleep patterns of the study population
时间窗: Baseline
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
次要结局
- Cardiovascular profile(Baseline)
- Hormonal profile(Baseline)
- Metabolic profile(Baseline)
- Inflammatory profile(Baseline)
研究者
Monica Levy Andersen
Professor
Federal University of São Paulo