Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- obstructive apnea-hypopnea index (oAHI)
研究概览
简要总结
This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced.
Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit.
- •Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)
排除标准
- •Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
- •Currently using and adherent to positive airway pressure therapy (>4 hours per night for 70% of nights in the past 30 days based on device download or parent report)
- •Monoamine oxidase inhibitor use
- •Urinary retention
- •Prematurity < 32 weeks estimated gestational age
- •Seizure disorder
- •Untreated or inadequately treated hypothyroidism
- •Significant traumatic brain injury
- •Congenital heart disease and not cleared to participate by the patient's cardiologist
- •History of current, untreated depression
- •History of liver disease
- •3+ or greater tonsillar hypertrophy
- •Positive urine pregnancy test
- •Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation <90%)
- •Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5)
- •Absence of OSA defined as total AHI <5 on baseline polysomnography
研究组 & 干预措施
Ato-oxy
0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin
干预措施: Atomoxetine and Oxybutynin (ato-oxy) (Drug)
结局指标
主要结局
obstructive apnea-hypopnea index (oAHI)
时间窗: 6 months
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline (% change)
次要结局
- Obstructive Sleep Apnea-18 score (OSA-18)(6 months)
- Paired Associates Learning test(6 months)