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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05382494




Registration number
NCT05382494
Ethics application status
Date submitted
16/05/2022
Date registered
19/05/2022

Titles & IDs
Public title
Intranasal Steroid as Medical Therapy For Sleep-Disordered Breathing in Children
Scientific title
Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial
Secondary ID [1] 0 0
RCH HREC 81746
Universal Trial Number (UTN)
Trial acronym
MIST+
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disorder; Breathing-Related 0 0
Snoring 0 0
Obstructive Sleep Apnea of Child 0 0
Sleep Disorders in Children 0 0
Tonsillar Hypertrophy 0 0
Adenoidal Disorder 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mometasone Furoate 50mcg Nasal Spray
Treatment: Drugs - Sodium Chloride 0.9 % Nasal Spray

Experimental: Intranasal Steroids -

Placebo comparator: Intranasal Saline -


Treatment: Drugs: Mometasone Furoate 50mcg Nasal Spray
Intranasal steroid (Mometasone Furoate 50mcg) one spray each nostril daily for 6 weeks

Treatment: Drugs: Sodium Chloride 0.9 % Nasal Spray
Intranasal saline spray (Sodium Chloride 0.9%) one spray each nostril daily for 6 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
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).
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
An improvement of score in parent completed Glasgow Children's Benefit Inventory (GCBI) at week 6 when compared with baseline measured at the start of the intervention period (week 0).
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 weeks
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 12 weeks
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Proportion of parent responders who think their child needs surgery to remove their tonsils or adenoids (T&A) at 6 months
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids surgery (T&A) if recommended to them at 6 weeks
Timepoint [10] 0 0
6 weeks
Secondary outcome [11] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 weeks
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 6 months
Timepoint [12] 0 0
6 months
Secondary outcome [13] 0 0
Proportion of parent responders who would be happy to proceed with tonsils and adenoids (T&A) surgery if recommended to them at 12 months
Timepoint [13] 0 0
12 months
Secondary outcome [14] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 6 weeks
Timepoint [14] 0 0
6 weeks
Secondary outcome [15] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 12 weeks
Timepoint [15] 0 0
12 weeks
Secondary outcome [16] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 6 months
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Proportion of parents who think their child still needs a review by a hospital specialist at 12 months
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 weeks
Timepoint [18] 0 0
6 weeks
Secondary outcome [19] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 weeks
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 6 months
Timepoint [20] 0 0
6 months
Secondary outcome [21] 0 0
Proportion of parents who would be happy to have their child taken off the hospital clinic waiting list at 12 months
Timepoint [21] 0 0
12 months
Secondary outcome [22] 0 0
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 6 weeks (Likert Scale)
Timepoint [22] 0 0
6 weeks
Secondary outcome [23] 0 0
Parent satisfaction with run-in phase and treatment phase therapy as an alternative to tonsillectomy and/or adenoidectomy at 12 weeks (Likert Scale)
Timepoint [23] 0 0
12 weeks
Secondary outcome [24] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) defined by Ear Nose Throat (ENT) surgery at 6 months
Timepoint [24] 0 0
6 months
Secondary outcome [25] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing defined by ENT surgery at 12 months
Timepoint [25] 0 0
12 months
Secondary outcome [26] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 6 months
Timepoint [26] 0 0
6 months
Secondary outcome [27] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Brouillette questionnaire at 12 months.
Timepoint [27] 0 0
12 months
Secondary outcome [28] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 6 months
Timepoint [28] 0 0
6 months
Secondary outcome [29] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on symptoms of SDB reported in parent-completed Pediatric Quality of Life Inventory (PedsQL) at 12 months
Timepoint [29] 0 0
12 months
Secondary outcome [30] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 6 months
Timepoint [30] 0 0
6 months
Secondary outcome [31] 0 0
Progression to Tonsillectomy and/or Adenoidectomy for Sleep Disordered Breathing (SDB) based on treatment for Sleep Disordered Breathing (SDB) at 12 months.
Timepoint [31] 0 0
12 months
Secondary outcome [32] 0 0
Number of adverse events (AEs) throughout the treatment phase
Timepoint [32] 0 0
6 weeks
Secondary outcome [33] 0 0
Number of adverse events (AEs) within the first week of the treatment
Timepoint [33] 0 0
1 week
Secondary outcome [34] 0 0
Compliance of medical therapy measured by weight of sent and returned bottles of medication
Timepoint [34] 0 0
-6 weeks and 6 weeks (start of run-in phase to end of treatment phase)
Secondary outcome [35] 0 0
Clinical factors at baseline that are associated with response to interventions, based on statistical analysis
Timepoint [35] 0 0
6 weeks

Eligibility
Key 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.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
130
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children's Hospital - Clayton
Recruitment hospital [2] 0 0
Royal Children's Hospital / Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Children's Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten Perrett
Address 0 0
Murdoch Children&amp;#39;s Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Perrett
Address 0 0
Country 0 0
Phone 0 0
61399366278
Fax 0 0
Email 0 0
kirsten.perrett@rch.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data set that will be collected for this analysis of the MIST+ trial will be available six months after publication of the primary outcome. The study protocol may be obtained from the Murdoch Children's Research Institute. 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.

Should the study investigators be unavailable, this role is delegated to the Murdoch Children's Research Institute. Data will only be shared with a recognised research institute, which has approved the proposed analysis plan.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Six months after the publication of the primary outcome
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.melbournechildrens.com/mctc/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05382494