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

NCT05382494 | Completed Phase 4 DMC

• 1 other identifier: RCH HREC 81746
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire </=-1 at 6 weeks

  The Brouillette questionnaire is a validated symptom questionnaire that investigates the presence of respiratory sleep disorders and the frequency of apnoea and pathological snoring. Each item is scored from 0 to 3 (0 = absence of symptoms, 1 = occasional symptoms, 2 = frequent symptoms, and 3 = constant symptoms), and the overall score is directly proportional to disease severity. The proportion of participants in each treatment arm with resolution of symptoms at 6 weeks will be calculated with 95% confidence intervals (CIs). The treatment arms will be compared using a Mantel Haenszel chi-squared test.

  6 weeks

Secondary Outcomes (35)

• The proportion of participants with resolution of significant Sleep Disordered Breathing (SDB) symptoms as defined by the parent completed Brouillette questionnaire < -1 at 12 weeks

  12 weeks

• An improvement of score in parent completed Pediatric Sleep Questionnaire-sleep disordered breathing subscale (PSQ-SDB subscale) at week 6 when compared with baseline measured at the start of the intervention period (week 0)

  6 weeks

• An improvement of score in parent completed Obstructive Sleep Apnoea-18 (OSA-18) questionnaire at week 6 when compared with baseline measured at the start of intervention period (week 0).

  6 weeks

• An improvement of score in parent completed Pediatric Quality of Life Inventory (PedsQL) at week 6 when compared with baseline measured at the start of the intervention period (week 0).

  6 weeks

• An improvement of score in parent completed Strengths and Difficulties Questionnaire (SDQ) at week 6 when compared with baseline measured at the start of the intervention period (week 0).

  6 weeks

Study Arms (2)

Intranasal Steroids

EXPERIMENTAL

Drug: Mometasone Furoate 50mcg Nasal Spray

Intranasal Saline

PLACEBO COMPARATOR

Drug: Sodium Chloride 0.9 % Nasal Spray

Interventions

Mometasone Furoate 50mcg Nasal Spray DRUG

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

Also known as: Sensease Nasal Allergy Relief Nasal Spray

Intranasal Steroids

Sodium Chloride 0.9 % Nasal Spray DRUG

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

Also known as: Intranasal Saline Spray

Intranasal Saline

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Monash Health: collaborator
• Royal Children's Hospital: collaborator

Study Sites (2)

Monash Children's Hospital

Clayton, Victoria, 3168, Australia

Location

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

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

• Nixon GM, Anderson D, Baker A, Davidson A, Griffiths A, Grobler AC, Pinczower G, Rimmer J, Rose E, Selman CJ, Simpson CM, Vandeleur M, Perrett KP. Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial. JAMA Pediatr. 2026 Jan 20:e255717. doi: 10.1001/jamapediatrics.2025.5717. Online ahead of print.

  PMID: 41557344 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Snoring

Interventions

Mometasone Furoate; Nasal Sprays; Sodium Chloride

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiratory Sounds; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kirsten Perrett

  Murdoch Children&amp;#39;s Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, double-blind, randomised control trial

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: December 5, 2022
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Six months after the publication of the primary outcome
• Access Criteria: Prior to releasing any data, the following are required: a data access agreement must be signed between relevant parties; the MIST+ trial investigators must see and approve the analysis plan describing how the data will be analysed; there must be an agreement around appropriate acknowledgment; and any additional costs involved must be covered.

Locations

AU (2)