Snoring kids may skip surgery: nasal spray trial shows promise
NCT ID NCT05382494
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a steroid nasal spray (mometasone furoate) in 130 children aged 3-12 who snore and have sleep-disordered breathing. The goal was to see if the spray could relieve symptoms enough to avoid surgery to remove tonsils or adenoids. Children used the spray daily for 6 weeks, and their symptoms were tracked using a parent questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mometasone Furoate nasal spray
- What this could lead to
- If it works, this nasal spray could offer a non-surgical option for children with snoring and sleep-disordered breathing, potentially reducing the need for tonsil or adenoid removal.
- What could go wrong
- This is a small, completed Phase 4 trial. The steroid spray may not work better than saline, and long-term effects in children are not fully known. Results may not apply to all kids.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
130 people
The number who actually took part.
- Started
-
Dec 2022
- Finished
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Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
3 to 12 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Monash Children's Hospital
Clayton, Victoria, 3168, Australia
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Royal Children's Hospital / Murdoch Children's Research Institute
Parkville, Victoria, 3052, Australia
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Other studies related to the condition(s) this trial covers.
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