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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Australia
Monash Children's Hospital
Clayton
Royal Children's Hospital / Murdoch Children's Research Institute
Parkville
Time Frame
Start Date: 2022-12-05
Completion Date: 2025-07-17
Participants
Target number of participants: 130
Treatments
Experimental: Intranasal Steroids
Placebo_comparator: Intranasal Saline
Related Therapeutic Areas
Sponsors
Collaborators: Monash Health, Royal Children's Hospital
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov