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

NCT05382494 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Monash Health

    collaborator OTHER

  • Royal Children's Hospital

    collaborator OTHER

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Kirsten Perrett · Murdoch Children's Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382494 on ClinicalTrials.gov