Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
研究概览
简要总结
MIST+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. Children aged 3-12 are invited to take part. Snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. Currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. This research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.
详细描述
MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The saline is the same colour and consistency to the active drug (intranasal steroid) and will have the same sensation when sprayed into the nostril. Randomisation will be stratified by site, Royal Children's Hospital (RCH) and Monash Health (MH), with permuted random block randomisation. An independent statistician in the Clinical Epidemiology and Biostatistics Unit (CEBU) at Murdoch Children's Research Institute (MCRI) will arrange the randomisation schedules, which will be given to the Clinical Trials Pharmacy at RCH and MH. This schedule will remain blinded to all other study staff.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must meet all of the following criteria to be enrolled in this trial:
- •Is between the ages of 3 and 12 years inclusive at the time of randomisation
- •Has symptoms of Sleep Disordered Breathing (SDB) as determined by a Brouillette score ≥ -1 on telehealth/phone screening
- •Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •Has a BMI over the 97th centile for age and gender
- •Has a history of tonsillectomy and/or adenoidectomy
- •Has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders
- •Has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis
- •Has a history of nasal surgery or trauma which has not fully healed
- •Has active tonsillitis or nasal infection (must be resolved prior to randomisation)
- •Is assessed to have stertor (snoring) while awake at rest
- •Has a known hypersensitivity to the study drug or its formulation
- •Has used oral, intravenous, or intranasal steroids in the past 6 weeks. (Inhaled steroids for asthma will be allowed concomitantly during the study)
- •Daily use of antihistamine or decongestant nasal sprays
- •Is known to require systemic steroids prior to the completion of the study treatment phase
- •Has had treatment with any other investigational drug within 6 months prior to randomisation
- •Is unable to provide consent without the aid of an interpreter.
- •In the opinion of the Investigator may be unable to follow the protocol
研究组 & 干预措施
Intranasal Steroids
干预措施: Mometasone Furoate 50mcg Nasal Spray (Drug)
Intranasal Saline
干预措施: Sodium Chloride 0.9 % Nasal Spray (Drug)
结局指标
主要结局
The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks
时间窗: 6 weeks
The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.
次要结局
- The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks(12 weeks)
- An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)(6 weeks)
- An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).(6 weeks)
- An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).(6 weeks)
- Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks(12 weeks)
- Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months(6 months)
- Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks(6 weeks)
- Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks(12 weeks)
- Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months(6 months)
- Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months(12 months)
- Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks(6 weeks)
- Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks(12 weeks)
- Proportion of parents who think their child still needs a review by a hospital specialist at 6 months(6 months)
- Proportion of parents who think their child still needs a review by a hospital specialist at 12 months(12 months)
- Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks(6 weeks)
- Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks(12 weeks)
- Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months(6 months)
- Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months(12 months)
- Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)(6 weeks)
- Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)(12 weeks)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months(6 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months(12 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months(6 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.(12 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months(6 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months(12 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months(6 months)
- Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.(12 months)
- Number of adverse events (AEs) throughout the treatment phase(6 weeks)
- Compliance of medical therapy measured by weight of sent and returned bottles of medication(-6 weeks and 6 weeks (start of run-in phase to end of treatment phase))
- Clinical factors at baseline that are associated with response to interventions, based on statistical analysis(6 weeks)
- Number of adverse events (AEs) within the first week of the treatment(1 week)
- An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).(6 weeks)
- An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).(6 weeks)
- Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks(6 weeks)