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Snoring kids may skip surgery: nasal spray trial shows promise

NCT ID NCT05382494

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

  • Royal Children's Hospital / Murdoch Children's Research Institute

    Parkville, Victoria, 3052, Australia

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