None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: SDB diagnosis.
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.
Outcome results
None listed