Dexamethasone as a Novel Treatment for Obstructive Sleep Apnea in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Obstructive apnea-hypopnea index
研究概览
简要总结
This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.
详细描述
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas.
The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects.
Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown.
The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial.
Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI >5 events/hour)
- •Aged 2-10 years
- •Presence of adenotonsillar hypertrophy
- •Ability to take oral medication and be willing to adhere to the dosing regimen
- •Informed consent provided in accordance with institutional policies
排除标准
- •Previous adenotonsillectomy
- •Presence of symptoms of an upper respiratory tract infection
- •Co-existing central sleep apnea
- •Hypertension
- •Prior or current evidence for abnormal glucose tolerance
- •Contraindication for dexamethasone or components of dexamethasone oral suspension,
- •Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention
- •OSA with associated oxygen desaturations <90% for 2 continuous minutes
- •Need for non-invasive ventilation long-term due to underlying disease
- •Current systemic fungal infections
- •Patients with clinically relevant varicella exposure
研究组 & 干预措施
Placebo Treatment
Placebo control
干预措施: Placebo Control (Drug)
Dexamethasone Treatment
Oral Dexamethasone treatment
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Obstructive apnea-hypopnea index
时间窗: Baseline and 2-4 weeks
Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to \<5 events/hr; moderate OSA is defined as OAHI ≥5 to \<10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr
次要结局
- Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score(Baseline and 2-4 weeks)
- Soft tissue size (Adenoids, Tonsils & Turbinates)(Baseline and 2-4 weeks)
- Participant recruitment rate(From study start to completion; up to 6 months)
- Participant adherence rate(From study start to completion; up to 6 months)
- Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ)(Baseline and 2-4 weeks)
- Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey.(Baseline and 2-4 weeks)
- Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline(At baseline)
- Participant retention rate(From study start to completion; up to 6 months)
- Adverse events(From study start to completion; up to 6 months)
- Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa)(At baseline)
研究者
Indra Narang
Senior Associate Scientist
The Hospital for Sick Children