Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability
研究概览
简要总结
To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndrome (DS).
详细描述
This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS treated with PAP and their children will be enrolled. The study comprises one 30-minute open-ended semi-structured interview per caregiver. The duration of the interview is approximate. It will last up to 30 minutes as some families may want to include more details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients
- •Children with DS and OSAS treated with PAP for at least 6 months
- •Children aged between 6 and 17.5 years
- •English proficiency
- •Inclusion Criteria -- Caregivers
- •Parent or legal guardian of an eligible patient subject
- •English proficiency
- •Must live with the patient subject at least 4 nights of the week
排除标准
- •- Patients
- •In foster care
- •Diagnosed with major illness, such as leukemia or severe cyanotic congenital heart disease listed for cardiac transplant as these severe diseases may add confounders
- •Exclusion Criteria -- Caregivers
- •Foster parent
研究组 & 干预措施
Participants treated with PAP
This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome.
干预措施: Open-ended semi-structured interviews (Behavioral)
结局指标
主要结局
Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability
时间窗: one day
PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome.
次要结局
未报告次要终点