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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2025-07-17

Brief Summary

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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.

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Detailed Description

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MIST+ is a multi centre, double-blind, placebo controlled trial. Children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). Participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre, double-blind, randomised control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The saline is the same colour and consistency to the active drug (intranasal steroid) and will have the same sensation when sprayed into the nostril. Randomisation will be stratified by site, Royal Children's Hospital (RCH) and Monash Health (MH), with permuted random block randomisation. An independent statistician in the Clinical Epidemiology and Biostatistics Unit (CEBU) at Murdoch Children's Research Institute (MCRI) will arrange the randomisation schedules, which will be given to the Clinical Trials Pharmacy at RCH and MH. This schedule will remain blinded to all other study staff.

Study Groups

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Intranasal Steroids

Group Type EXPERIMENTAL

Mometasone Furoate 50mcg Nasal Spray

Intervention Type DRUG

Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks

Intranasal Saline

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0.9 % Nasal Spray

Intervention Type DRUG

Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks

Interventions

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Mometasone Furoate 50mcg Nasal Spray

Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks

Intervention Type DRUG

Sodium Chloride 0.9 % Nasal Spray

Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Sensease Nasal Allergy Relief Nasal Spray Intranasal Saline Spray

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No