NCT05382494

Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children

Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Sleep Disorder; Breathing-Related
• Snoring
• Obstructive Sleep Apnea of Child
• Sleep Disorders in Children
• Tonsillar Hypertrophy
• Adenoidal Disorder

Interventions

Type	Name	Description
DRUG	Mometasone Furoate 50mcg Nasal Spray	Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks
DRUG	Sodium Chloride 0.9 % Nasal Spray	Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks

Timeline

• Start date: 2022-12-05
• Primary completion: 2025-07-17
• Completion: 2025-07-17
• First posted: 2022-05-19
• Last updated: 2025-09-30

Locations

2 sites across 1 country: Australia