Cochrane · intervention · CD005520
Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children
Carvalho, FR, Lentini‐Oliveira, DA, Prado, LBF, et al. · Cochrane Database of Systematic Reviews · 2016 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
27
current version
GRADE rated
10
No studies
13
Included studies
1
as reported
No studies 13 · 48.1%Ungraded 4 · 14.8%Very low 10 · 37%Low 0 · 0%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Children and adolescents. We included trials in which over 80% of included participants were 15 years old or younger, receiving oral appliances or functional orthopaedic appliances to treat obstructive sleep apnoea. Criteria for abnormal values for obstructive apnoea considered as one or more apnoea, of any length, per hour of sleep, measured by standard polysomnography. Trials including patients with a cleft lip or palate or both were excluded. There was no gender restriction. | Children aged 4 to 10 years (mean 7.1 +/- 2.6), 20 male and 12 female, with apnoea index > 1 and dysgnathia; 32 randomised, 23 analysed. |
| Intervention | All types of oral and functional appliances used to treat obstructive sleep apnoea, compared with placebo or no treatment, including: Bimler appliance, Frankel appliance, Harvold appliance, Andresen appliance, bionator, bite block, Herbst appliance, Herren activator and Woodside activator. | Personalised active oral appliance (n=19) |
| Comparison | Placebo or no treatment | No treatment (n=13) |
| Outcomes | Primary: Reduction to less than one episode of apnoea per hour (polysomnography). Secondary: (1) Reduction of apnoea episodes (polysomnography); (2) Reduction of upper airway resistance syndrome (UARS) and body-weight/BMI development; (3) Reduction of snoring (polysomnography); (4) Signs and symptoms of respiratory disease (mouth breathing, nasal airway resistance); (5) Signs and symptoms of atypical swallowing and speech production; (6) Daytime and nocturnal symptoms; (7) Change of mandibular length (cephalometric); (8) Sagittal maxilla-mandible relationship (cephalometric); (9) Width between cuspids and first molars (plaster models); (10) Arch perimeter (plaster models); (11) Overbite and overjet (plaster models); (12) Alteration of growth pattern; (13) Quality of life; (14) Side effects (tolerability); (15) Economic evaluation (costs); (16) Educational outcomes: cognitive function. | Apnoea-hypopnoea index measured by polysomnography (n=1); Daytime symptoms: sleepiness, irritability, tiredness, school problems, morning headache, thirstiness in the morning, oral breathing and nasal stuffiness measured by questionnaire (n=1); Night-time symptoms: habitual snoring, restless sleep and nightmares measured by questionnaire (n=1) |
| Study designs | Randomised controlled trials (RCTs); quasi-randomised trials (alternation, date of birth, record number) included and subjected to a sensitivity analysis. | Quasi-randomised controlled trial (n=1) |
| Timing | Not reported | 6 months |
Search date: 2016-04. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; LILACS BIREME Virtual Health Library; BBO BIREME Virtual Health Library; SciELO Web of Science; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform
Questions and results
Show all 3 versionsOral appliance or functional orthopaedic appliance vs Placebo or no treatment
Population: Children with obstructive sleep apnoea (aged 15 years or younger)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Daytime symptom: thirstiness in the morning (questionnaire) 6 months | RR 0.16 [0.02, 1.22] | 1 study · 23 participants | Ungraded |
Signs and symptoms of atypical swallowing and speech production disturbance | The included study did not assess this outcome. | 0 studies | No studies |
Nocturnal symptom: nightmares (questionnaire) 6 months | RR 0.22 [0.01, 4.93] | 1 study · 23 participants | Ungraded |
Alteration of growth pattern (cephalometric data or facial analysis) | The included study did not assess this outcome. | 0 studies | No studies |
Daytime symptom: sleepiness (Brouillette questionnaire) 6 months | RR 0.64 [0.11, 3.78] 222 per 1000 vs 142 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Change of the arch perimeter (plaster models) | The included study did not assess this outcome. | 0 studies | No studies |
Daytime symptom: irritability (Brouillette questionnaire) 6 months | RR 0.32 [0.07, 1.41] 444 per 1000 vs 142 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Signs and symptoms of respiratory disease: mouth breathing, nasal airway resistance (clinical assessment/rhinomanometry/fibroscopy) | The included study did not assess this outcome. | 0 studies | No studies |
Reduction of upper airway resistance syndrome (UARS) and body-weight/BMI development (polysomnography) | The included study did not assess this outcome. | 0 studies | No studies |
Reduction of snoring (polysomnography) | The included study did not assess this outcome. | 0 studies | No studies |
Daytime symptom: tiredness (Brouillette questionnaire) 6 months | RR 0.26 [0.06, 1.05] 556 per 1000 vs 144 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Reduction of apnoea to less than one episode per hour (polysomnography) 6 months | It proved impossible to know how many patients had apnoea index < 1 (primary outcome). | 1 study | Ungraded |
Reduction of apnoea episodes (apnoea-hypopnoea index) 6 months | RR 0.39 [0.20, 0.76] 1000 per 1000 vs 390 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Daytime symptom: morning headache (Brouillette questionnaire) 6 months | RR 0.39 [0.12, 1.23] 556 per 1000 vs 217 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Side effects and tolerability (patient self report) 6 months | Tolerability: 73.7% fitted with oral appliance (14/19 children) tolerated the treatment well and 26.3% (five children) discontinued therapy. Side effects: the included study did not assess this outcome. | 1 study · 19 participants | Ungraded |
Nocturnal symptom: habitual snoring (questionnaire) 6 months | RR 0.18 [0.06, 0.55] | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Quality of life (validated scale) | The included study did not assess this outcome. | 0 studies | No studies |
Economic evaluation: costs | The included study did not assess this outcome. | 0 studies | No studies |
Improvement of the overbite and overjet (plaster models) | The included study did not assess this outcome. | 0 studies | No studies |
Change of mandibular length (cephalometric data) | The included study did not assess this outcome. | 0 studies | No studies |
Educational outcomes: cognitive function (validated scale) | The included study did not assess this outcome. | 0 studies | No studies |
Improvement on sagittal relationship between the maxilla and mandible (cephalometric data) | The included study did not assess this outcome. | 0 studies | No studies |
Daytime symptom: oral breathing (questionnaire) 6 months | RR 0.16 [0.04, 0.59] 889 per 1000 vs 142 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Nocturnal symptom: restless sleep (questionnaire) 6 months | RR 0.21 [0.05, 0.84] | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Daytime symptom: school problems (Brouillette questionnaire) 6 months | RR 0.64 [0.11, 3.78] 222 per 1000 vs 142 per 1000 | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Daytime symptom: nasal stuffiness (questionnaire) 6 months | RR 0.18 [0.05, 0.69] | 1 study · 23 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Changes of the width between cuspids and first molars (plaster models) | The included study did not assess this outcome. | 0 studies | No studies |