The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular rethognathia: a study protocol for a multicenter randomized controlled trial
Background: Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) is a multifactorial syndrome caused by many risk factors, such as craniofacial anomalies, adenotonsillar hypertrophy, obesity and airway inflammation. Although new treatment patterns have recently been proposed, treatment methods for children remain particularly challenging and controversial. This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for mild OSAHS children with mandibular rethognathia.
Methods: A sample of 352 children with mild OSAHS and mandibular rethognathia, aged between 7 and 10 years, will be enrolled in the study. They will be randomized into four groups – the drug treatment group, the surgical treatment group,the orthodontic treatment group, or the surgery and postoperative orthodontic group. After randomization they will receive treatments within 4 weeks. Outcome assessment will take place at the following points: (1)baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, and (3) 24 months after the treatment starting point. The primary endpoint of the trial is the mean change of obstructive apnea/hypopnea index. Other endpoints will consist of the lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnogram, subjective symptoms (assessed by the OSA-20 questionnaire), cephalometric measurements and morphologic analysis of the upper airway.
Discussion: The results of this study will provide valuable evidence for the merits and long-term efficacy of different treatment approaches and contribute to facilitating the multidisciplinary treatment of pediatric OSAHS.
Trial registration: Clinicaltrials.gov, ID: NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).
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Posted 19 May, 2020
On 30 Jun, 2020
On 08 May, 2020
On 07 May, 2020
On 07 May, 2020
Received 07 May, 2020
Received 07 May, 2020
On 06 May, 2020
Invitations sent on 06 May, 2020
On 20 Mar, 2020
Received 03 Apr, 2020
On 03 Apr, 2020
On 02 Apr, 2020
Received 28 Mar, 2020
Received 28 Mar, 2020
On 27 Mar, 2020
On 26 Mar, 2020
Invitations sent on 26 Mar, 2020
On 26 Mar, 2020
On 21 Mar, 2020
On 23 Feb, 2020
The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular rethognathia: a study protocol for a multicenter randomized controlled trial
Posted 19 May, 2020
On 30 Jun, 2020
On 08 May, 2020
On 07 May, 2020
On 07 May, 2020
Received 07 May, 2020
Received 07 May, 2020
On 06 May, 2020
Invitations sent on 06 May, 2020
On 20 Mar, 2020
Received 03 Apr, 2020
On 03 Apr, 2020
On 02 Apr, 2020
Received 28 Mar, 2020
Received 28 Mar, 2020
On 27 Mar, 2020
On 26 Mar, 2020
Invitations sent on 26 Mar, 2020
On 26 Mar, 2020
On 21 Mar, 2020
On 23 Feb, 2020
Background: Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) is a multifactorial syndrome caused by many risk factors, such as craniofacial anomalies, adenotonsillar hypertrophy, obesity and airway inflammation. Although new treatment patterns have recently been proposed, treatment methods for children remain particularly challenging and controversial. This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for mild OSAHS children with mandibular rethognathia.
Methods: A sample of 352 children with mild OSAHS and mandibular rethognathia, aged between 7 and 10 years, will be enrolled in the study. They will be randomized into four groups – the drug treatment group, the surgical treatment group,the orthodontic treatment group, or the surgery and postoperative orthodontic group. After randomization they will receive treatments within 4 weeks. Outcome assessment will take place at the following points: (1)baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, and (3) 24 months after the treatment starting point. The primary endpoint of the trial is the mean change of obstructive apnea/hypopnea index. Other endpoints will consist of the lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnogram, subjective symptoms (assessed by the OSA-20 questionnaire), cephalometric measurements and morphologic analysis of the upper airway.
Discussion: The results of this study will provide valuable evidence for the merits and long-term efficacy of different treatment approaches and contribute to facilitating the multidisciplinary treatment of pediatric OSAHS.
Trial registration: Clinicaltrials.gov, ID: NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).
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