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Trial registered on ANZCTR


Registration number
ACTRN12614001013651
Ethics application status
Approved
Date submitted
9/09/2014
Date registered
19/09/2014
Date last updated
19/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a mandibular advancement appliance on Sleep Disordered Breathing in children
Scientific title
Efficacy of a mandibular advancement appliance on Sleep Disordered Breathing (Snoring and Obstructive Sleep Apnoea) in children
Secondary ID [1] 285217 0
Nil
Universal Trial Number (UTN)
U1111-1160-8387
Trial acronym
Kids Snoring Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing in Chlidren 292838 0
Condition category
Condition code
Respiratory 293142 293142 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mandibular Advancement Splints (MAS)
The oral appliance that will be used in the study is a Twin-block design consisting of two removable plates; one is worn on the upper arch, the other on the lower. Each plate has matching pieces which encourage the lower jaw to posture or slide forward as the teeth come together(active MAS).

The non-active appliance (sham MAS)
The Sham appliance consists of an upper and lower acrylic plate resembling the design of the active MAS, but without any component to protrude the mandible.



Children with Sleep Disordered Breathing (SDB) will be recruited and randomly assigned to two groups; both groups will receive the same treatment with active MAS and non-active MAS but in different sequences; the first group will receive three weeks treatment with active MAS, two week break (a wash-out period), and three weeks treatment with non-active MAS,the second group will receive the appliances in a reversed order.

throughout the treatment periods a participant will be asked to wear the appliances while sleeping during the night time in addition to 2 hours during the daytime, The daily adherence to use the appliances will be monitored by providing the parents/guardians with a diary to record the actual time of appliance wearing.
Intervention code [1] 290115 0
Treatment: Devices
Comparator / control treatment
Placebo (Sham MAS) will be used as a control intervention, the same participant will get the active intervention with the active mandibular advancement splints and the participant will receive the treatment with splints resembling the design of the active MAS, but without any component to protrude the mandible. (Sham MAS)
Control group
Placebo

Outcomes
Primary outcome [1] 293025 0
Apnea/Hypopnea Index (AHI – primary outcome)
This is defined as number of apnea and hypopnea events recorded per hour of sleep. An apnea episode is defined as cessation of breathing for 10 seconds or longer. A hypopnea episode is defined as reduced respiratory airflow by 30% with a 4% decrease in oxygen saturation.
AHI will be assessed using the portable monitoring device.
Timepoint [1] 293025 0
This monitoring will be carried out four times during the study at the beginning and at the end of each treatment period .
Primary outcome [2] 293026 0
Snoring frequency and intensity
Snoring sounds will be assessed using the portable PSG equipment. Reports of snoring frequency and intensity will also be collected by parents using daily diaries.
Timepoint [2] 293026 0
Snoring frequency and intensity will be assessed at the beginning and the end of each treatment period. Reports of snoring frequency and intensity will also be collected by parents using daily diaries.
Secondary outcome [1] 310205 0
Sleep Questionnaires
Sleep Disordered Breathing (SDB) associated symptoms will be assessed using the Pediatric Sleep Questionnaire. A questionnaire of sleep related breathing disorder scale (PSQ-SRBD scale) will also be completed by parents to ascertain the quality of the child’s sleep including difficulties in getting to sleep, frequency of waking during the night, and alertness in the morning and daytime signs of sleepiness. It will also include questions about the history of the breathing difficulties during sleep, snoring, family history of SDB, and levels of household smoking.
Timepoint [1] 310205 0
These questionnaires will be administered before and after each treatment period.
Secondary outcome [2] 310206 0
Growth hormone levels
Blood samples will be taken from SDB children twice in the middle of each treatment period. A specialist in venipuncture will collect the samples to minimize discomfort and potential complications of venipuncture. Growth hormone will be assessed indirectly by determination of insulin-like growth factor-1 (IGF-1) levels.
Timepoint [2] 310206 0
after ten days of wearing the mandibular advancement splint and the sham splints for each participant. Then the a comparison will be done between the two times
Secondary outcome [3] 310207 0
Parent-report of nocturnal enuresis
A child will be diagnosed as having urine incontinence when it occurs at least one night per week. This will be assessed during both treatment periods using diaries.
Timepoint [3] 310207 0
This will be assessed during both treatment periods using diaries on weekly bases.
Secondary outcome [4] 310208 0
Neurobehavioral assessment
Behavioral changes will be assessed using the BASC-2 rating scale.
Timepoint [4] 310208 0
The BASC-2 questionnaire will be applied for four times during the study at the start and at the end of each treatment period.
Secondary outcome [5] 310209 0
Quality of life
Quality of life in SDB children will be assessed using the OSA-18 and the Pediatric Quality of Life Inventory 'Trademark' (PQoL).Parents or caregivers will rate the frequency of symptoms before treatment and at the end of each treatment period.
Timepoint [5] 310209 0
These questionnaires will be administered before and after each treatment period.
Secondary outcome [6] 310546 0
Daytime sleepiness and related behavioral disturbances will be assessed using the Epworth Sleepiness Scale (ESS).
Timepoint [6] 310546 0
This questionnaire will be administered before and after each period of treatment.

Eligibility
Key inclusion criteria
Inclusion criteria: SDB diagnosis.
Minimum age
8 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: severe OSA (AHI more than ten events per hour);craniofacial syndromes and genetic syndromes; neuromuscular diseases; body mass index at or above 95th percentile of normative values.

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)
participants will draw a sealed opaque envelops to determine in which sequence a participant will go:
1- The mandibular advancement splints (Active MAS) in the first period of the treatment of 3 weeks, 2 weeks period of wash- out , then treatment with the Sham MAS for a period of 3 weeks.

2- The Sham MAS in the first period of the treatment of 3 weeks, 2 weeks period of wash- out, then treatment with Active MAS for a period of 3 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Because of using cross over design then it is not necessary to wait for having a specific number of participants to start the research.
Participants will be recruited by advertising publicly and 16 participants will be allocated into two equal groups by a simple random way using sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6315 0
New Zealand
State/province [1] 6315 0
Dunedin

Funding & Sponsors
Funding source category [1] 289862 0
Government body
Name [1] 289862 0
The Ministry of Health Oral Health Research Fund
Address [1] 289862 0
NZDA House Building 1, 195 Main Highway Ellerslie, Auckland 1051 PO Box 28084, Remuera 1541
Country [1] 289862 0
New Zealand
Funding source category [2] 289863 0
Charities/Societies/Foundations
Name [2] 289863 0
New Zealand Association of Orthodontists, Foundation for Orthodontic Research & Education, NZAO(FORENZAO) Charitable Trust
Address [2] 289863 0
27 Waimea Road, Nelson, 7010 New Zealand
Country [2] 289863 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Sir John Walsh Research Institute, PO Box 56, University of Otago, Dunedin 9054, New Zealand
Country
New Zealand
Secondary sponsor category [1] 288545 0
None
Name [1] 288545 0
Address [1] 288545 0
Country [1] 288545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291586 0
the University of Otago Human Ethics Committee(Health)
Ethics committee address [1] 291586 0
Clocktower Building, University of Otago, PO Box 56
Dunedin 9054, New Zealand
Ethics committee country [1] 291586 0
New Zealand
Date submitted for ethics approval [1] 291586 0
Approval date [1] 291586 0
19/05/2014
Ethics approval number [1] 291586 0
H14/054
Ethics committee name [2] 291588 0
Ngai Tahu Research Consultation Committee
Ethics committee address [2] 291588 0
Ngai Tahu Research Consultation Committee
Research Division
University of Otago PO Box 56, Dunedin 9054 New Zealand
Ethics committee country [2] 291588 0
New Zealand
Date submitted for ethics approval [2] 291588 0
Approval date [2] 291588 0
15/04/2014
Ethics approval number [2] 291588 0
No number available

Summary
Brief summary
Sleep-Disordered Breathing (SDB) varies from habitual snoring to completely stopped breathing and can be found in up to 10% of New Zealand children. SDB can cause breathlessness and frequent waking during sleep due to partial or complete obstruction of the upper airway. It can also cause growth disorders, daytime sleepiness, educational concerns, and behavioral problems.
In the most severe cases, SDB can also lead to life-threatening events like heart failure. Therefore, SDB may have a significant impact on the well-being of children, and a considerable financial burden on the national health system. Thus, early diagnosis and treatment of SDB in children is vital to prevent health issues later.
Continuous positive air pressure and surgery (adenotonsillectomy) represent the primary treatment modalities for SDB in children. Mandibular Advancement Splints (MAS) represent an alternative treatment that is less invasive, cheaper, more comfortable and acceptable than other treatment modalities. While the efficacy of these appliances has been clearly demonstrated in adults, there is little information about their usefulness in children.
This project aims to determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. This project will utilise skills from multiple research groups, thus establishing a multidisciplinary research team for the study of SDB in children in New Zealand.
Children with SDB will be recruited and randomly assigned to two groups; both groups will receive the same treatment with active MAS and non-active MAS but in different sequences; the first group will receive three weeks treatment with active MAS, two weeks break, and three weeks treatment with non-active MAS, the second group will receive the appliances in a reversed order. Potential improvement in SDB symptoms and some other accompanied health related problems will be assessed using a portable breathing monitoring instrument, questionnaires, and collecting blood samples.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50902 0
Prof Mauro Farella
Address 50902 0
Discipline of Orthodontics, Department of Oral Sciences, School of Dentistry, University of Otago, 310 Great King Street, 9016 Dunedin, New Zealand.
Country 50902 0
New Zealand
Phone 50902 0
+64(3) 479 5852
Fax 50902 0
+643 479 7078
Email 50902 0
mauro.farella@otago.ac.nz
Contact person for public queries
Name 50903 0
Mr Ghassan Idris
Address 50903 0
Sir John Walsh Institute, School of Dentistry, University of Otago, 310 Great King Street, 9016 Dunedin, New Zealand.
Country 50903 0
New Zealand
Phone 50903 0
+6434795664
Fax 50903 0
Email 50903 0
idrgh523@student.otago.ac.nz
Contact person for scientific queries
Name 50904 0
Prof Mauro Farella
Address 50904 0
Discipline of Orthodontics, Department of Oral Sciences, School of Dentistry, University of Otago, 310 Great King Street, 9016 Dunedin, New Zealand.
Country 50904 0
New Zealand
Phone 50904 0
+64 3 479 5852
Fax 50904 0
+643 479 7078
Email 50904 0
mauro.farella@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable