Obstructive Sleep Apnea
Conditions
Brief summary
Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.
Detailed description
Cure rate of pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment adenotonsillectomy is 50-80%. Treatment alternatives are scarce, poorly effective and based upon low scientific evidence. This means one out of five patients will remain exposed to the well-known neurocognitive, behavioral and quality of life adverse effects of disease. Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion, has recently shown promising results in the treatment of pediatric OSAS based upon its effect on craniofacial and upper airway growth, usually limited in these patients. The investigators propose a randomized, prospective, controlled trial in patients with Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the treatment success rate avoiding morbimortality associated to disease persistence during childhood and development during adult life.
Interventions
PROCEDUREStandard clinical practice
Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.
DEVICEStandard clinical practice + Rapid Maxillary Expansion
Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children´s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton.
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Children (boys and girls) between 4 and 9 years of age. * Residual OSAS after adenotonsillectomy (described as an Apnea Hypopnea Index over 3 objectively measured by means of polysomnography). * Rapid maxillary expansion indication. * Parents or tutors sign Informed Consent.
Exclusion criteria
* Craniofacial syndromes or neurologic disease diagnosis. * Adenoid residual hypertrophy occluding \>50% nasal airway as measured by means of nasal flexible fiberoptic endoscopy and or tonsillar residual hypertrophy \>2 as measured by direct intraoral physical exam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | During sleep, an average of 10 hours | Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep-related quality of life | 2 years | Quality of life as described by OSA-18 questionnaire. |
| Craniofacial growth | 2 years | Craniofacial growth by lateral cephalometric radiograph. |
| Dental arch growth | 2 years | Dental arch growth as described by Moorrees et al 1969. |
| Adenotonsillar hypertrophy | 2 years | Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy. |
Countries
Spain
Outcome results
None listed