Status:
COMPLETED
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Monash Health
Royal Children's Hospital
Conditions:
Sleep Disorder; Breathing-Related
Snoring
Eligibility:
All Genders
3-12 years
Phase:
PHASE4
Brief Summary
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 pro...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05382494
Start Date
December 5 2022
End Date
July 17 2025
Last Update
September 30 2025
Active Locations (2)
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1
Monash Children's Hospital
Clayton, Victoria, Australia, 3168
2
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, Australia, 3052