A Randomized Controlled Trial Comparing Treatment Efficacy Between Rapid Palatal Expansion and Adenotonsillectomy in Pediatric Obstructive Sleep Apnea: A Pilot Study
- Conditions
- Pediatric obstructive sleep apnea (POSA)Pediatric Obstructive Sleep Apnea,Rapid Maxillary Exapnsion (RME),Adenotonsillectomy, Transverse Maxillary Hypoplasia
- Registration Number
- TCTR20230824001
- Lead Sponsor
- ational Research Council of Thailand (NRCT)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1.Patient has signs and symptoms of pediatric sleep apnea
2.Patient has a pediatric OSA diagnosis confirmed by an overnight Type I polysomnography.
3.Patient presents with adenotonsillar hypertrophy grade 2 or more based on clinical evaluation by a board certified ENT specialist.
4.Patient presents with narrow and constricted maxilla with or without posterior dental crossbite, diagnosed clinically by a board certified orthodontist.
5.Patient is between 4 to 10 years of age.
Presence of other significant pathologies, such as all craniofacial syndromes that could influence upper airway patency including cleft lip and palate, significant sagittal relationship (severe maxilla or mandible hypoplasia), severe obesity and past medical history that could prevent patients from undergoing adenotonsillectomy i.e. severe heart disease and diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSG 6 months after end of the first treatment (T1) AHI (Apnea-hypopnea Index), Mean Blood Oxygen Saturation, Lowest Blood Oxygen Saturation, Sleep architecture,Clinical examination 6 months after end of the first treatment (T1) Tonsillar scoring, Intercanine width and intermolar width, dental occlusion, Presence/Absence of posterior crossbite, palatal architecture,Radiographic Evaluation 6 months after end of the first treatment (T1) Md-Hyoid, Anterior Facial Height, Adenoid scoring
- Secondary Outcome Measures
Name Time Method Assessment of safety 6 months after end of the first treatment (T1) Report of complications from patients and parents ,Assessment of efficacy 6 months after end of the first treatment (T1) Improvement of the above parameters