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

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Collaborators: Monash Health; Royal Children's Hospital
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

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 Criteria:

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