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Study protocol
Yuehua Liu
Shanghai Stomatological Hospital, Fudan University
Corresponding Author
ORCiD: https://orcid.org/0000-0003-3033-8873
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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 been recently proposed, treatment methods for children have continued to be 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, or the surgical treatment group, or 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 points: (1) at baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, (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 questionnaire OSA-20), cephalometric measurements and Morphologic analysis of upper airway.
Discussion: The results of this study will provide valuable evidence for merits and long-term efficacy of different treatment approaches and contribute to facilitate the multidisciplinary treatment of pediatric OSAHS.
Trial registration: Clinicaltrials.gov, ID: NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).
Keywords
Pediatric obstructive sleep apnea/hypopnea syndrome, Mandibular rethognathia, Adenotonsillectomy, Orthodontic treatment, Multicenter randomized controlled trial
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CURRENT STATUS: Published
Published
On 30 Jun, 2020
No community comments so far
Editorial decision: Accept
On 08 May, 2020
Reviewer #1 agreed
On 07 May, 2020
Reviewer #2 agreed
On 07 May, 2020
Review #2 received
Received 07 May, 2020
Review #1 received
Received 07 May, 2020
Editor assigned
On 06 May, 2020
Reviewers invited
Invitations sent on 06 May, 2020
Submission checks complete
On 20 Mar, 2020
Version 1
Posted 24 Mar, 2020
No comments provided
Review #3 received
Received 03 Apr, 2020
Editorial decision: Major revision
On 03 Apr, 2020
Reviewer #3 agreed
On 02 Apr, 2020
Review #2 received
Received 28 Mar, 2020
Review #1 received
Received 28 Mar, 2020
Reviewer #2 agreed
On 27 Mar, 2020
Editor assigned
On 26 Mar, 2020
Reviewers invited
Invitations sent on 26 Mar, 2020
Reviewer #1 agreed
On 26 Mar, 2020
Submission checks complete
On 21 Mar, 2020
First submitted
On 23 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pediatrics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Yuehua Liu
Shanghai Stomatological Hospital, Fudan University
Corresponding Author
ORCiD: https://orcid.org/0000-0003-3033-8873
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 30 Jun, 2020
No community comments so far
Editorial decision: Accept
On 08 May, 2020
Reviewer #1 agreed
On 07 May, 2020
Reviewer #2 agreed
On 07 May, 2020
Review #2 received
Received 07 May, 2020
Review #1 received
Received 07 May, 2020
Editor assigned
On 06 May, 2020
Reviewers invited
Invitations sent on 06 May, 2020
Submission checks complete
On 20 Mar, 2020
Version 1
Posted 24 Mar, 2020
No comments provided
Review #3 received
Received 03 Apr, 2020
Editorial decision: Major revision
On 03 Apr, 2020
Reviewer #3 agreed
On 02 Apr, 2020
Review #2 received
Received 28 Mar, 2020
Review #1 received
Received 28 Mar, 2020
Reviewer #2 agreed
On 27 Mar, 2020
Editor assigned
On 26 Mar, 2020
Reviewers invited
Invitations sent on 26 Mar, 2020
Reviewer #1 agreed
On 26 Mar, 2020
Submission checks complete
On 21 Mar, 2020
First submitted
On 23 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Pediatrics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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 been recently proposed, treatment methods for children have continued to be 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, or the surgical treatment group, or 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 points: (1) at baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, (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 questionnaire OSA-20), cephalometric measurements and Morphologic analysis of upper airway.
Discussion: The results of this study will provide valuable evidence for merits and long-term efficacy of different treatment approaches and contribute to facilitate the multidisciplinary treatment of pediatric OSAHS.
Trial registration: Clinicaltrials.gov, ID: NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
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