Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial
Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children’s wellbeing, as it can cause growth disorders, educational and behavioral problems, and ev...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2016-08-01
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| Series: | Frontiers in Physiology |
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| Online Access: | http://journal.frontiersin.org/Journal/10.3389/fphys.2016.00353/full |
| _version_ | 1811254793576906752 |
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| author | Ghassan Idris Barbara Galland Christopher John Robertson Mauro Farella |
| author_facet | Ghassan Idris Barbara Galland Christopher John Robertson Mauro Farella |
| author_sort | Ghassan Idris |
| collection | DOAJ |
| description | Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children’s wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children.Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an ‘Active MAS’ (Twin-block) and a ‘Sham MAS’. Eligible participants will be children aged 8 to 12 years whose parents report they snore ≥ 3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for three weeks separated by a two-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime sleepiness, children behavior, and nocturnal enuresis. In addition, blood samples will be collected to assess growth hormone changes.Trial registration: This study was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): [ACTRN12614001013651] |
| first_indexed | 2024-04-12T17:13:06Z |
| format | Article |
| id | doaj.art-6a0e25c8ee09417687f24490ecdf48c9 |
| institution | Directory Open Access Journal |
| issn | 1664-042X |
| language | English |
| last_indexed | 2024-04-12T17:13:06Z |
| publishDate | 2016-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Physiology |
| spelling | doaj.art-6a0e25c8ee09417687f24490ecdf48c92022-12-22T03:23:44ZengFrontiers Media S.A.Frontiers in Physiology1664-042X2016-08-01710.3389/fphys.2016.00353198957Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trialGhassan Idris0Barbara Galland1Christopher John Robertson2Mauro Farella3University of OtagoUniversity of OtagoUniversity of OtagoUniversity of OtagoBackground: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children’s wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children.Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an ‘Active MAS’ (Twin-block) and a ‘Sham MAS’. Eligible participants will be children aged 8 to 12 years whose parents report they snore ≥ 3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for three weeks separated by a two-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime sleepiness, children behavior, and nocturnal enuresis. In addition, blood samples will be collected to assess growth hormone changes.Trial registration: This study was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): [ACTRN12614001013651]http://journal.frontiersin.org/Journal/10.3389/fphys.2016.00353/fullBehaviorGrowth HormoneQuality of LifeSnoringSleep ApneaSleep disordered breathing |
| spellingShingle | Ghassan Idris Barbara Galland Christopher John Robertson Mauro Farella Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial Frontiers in Physiology Behavior Growth Hormone Quality of Life Snoring Sleep Apnea Sleep disordered breathing |
| title | Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial |
| title_full | Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial |
| title_fullStr | Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial |
| title_full_unstemmed | Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial |
| title_short | Efficacy of a mandibular advancement appliance on sleep-disordered breathing in children: a study protocol of a crossover randomized controlled trial |
| title_sort | efficacy of a mandibular advancement appliance on sleep disordered breathing in children a study protocol of a crossover randomized controlled trial |
| topic | Behavior Growth Hormone Quality of Life Snoring Sleep Apnea Sleep disordered breathing |
| url | http://journal.frontiersin.org/Journal/10.3389/fphys.2016.00353/full |
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