Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children (MIST+)

Murdoch Childrens Research Institute

Status and phase

Completed

Phase 4

Conditions

Snoring

Sleep Disorders in Children

Sleep Disorder; Breathing-Related

Adenoidal Disorder

Obstructive Sleep Apnea of Child

Tonsillar Hypertrophy

Treatments

Drug: Sodium Chloride 0.9 % Nasal Spray

Drug: Mometasone Furoate 50mcg Nasal Spray

Study type

Interventional

Funder types

Other

Identifiers

NCT05382494

RCH HREC 81746

Details and patient eligibility

About

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.

Full description

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.

Enrollment

130 patients

Sex

All

Ages

3 to 12 years old

Volunteers

No Healthy Volunteers

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