Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634264
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Two Reeducation Methods in Children With Persistent Sleep Apnea a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERSIST-B-RCT
Brief Summary:
Myofunctional therapy has been shown to be effectively reduce symptoms of paediatric obstructive sleep apnea usually performed after adenotonsillectomy
This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation using a flexible oral appliance compared to nasal hygiene alone control group in a population of children scheduled for adenotonsillectomy
This study aims to evaluate the effectiveness of Passive Oral Myofunctional Reeducation using a flexible oral appliance compared to nasal hygiene alone control group in a population of children scheduled for adenotonsillectomy
Detailed Description:
Paediatric Obstructive Sleep Apnea PedOSA is a multifactorial condition associated with significant comorbidities affecting cardiovascular health cognitive development and quality of life Its main cause is adenotonsillar hypertrophy but some co-factors such as obesity orofacial dysfunctions and craniofacial abnormalities contribute to the severity of symptoms or their persistance after adeno-tonsillectomy
Aim Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes AHI of children and can serve as an adjunct to other therapies but the level of compliance is a limiting factor The investigators aim is to evaluate the effectiveness of Passive Oral Myofunctional Reeducation a flexible oral appliance in a group a children scheduled for adeno-tonsillectomy in association with nasal hygiene and to compare them with nasal hygiene alone control group
Methods The design of the study is a randomized Controlled Trial enrolling 60 children with significant obstructive sleep apnea and divided into 2 groups Group 1 using of a flexible oral appliance during quiet activities and sleep nasal hygiene and Group 2 using nasal hygiene alone control group The objective assessment of sleep parameters is performed at home using an ambulatory device AHI desaturation index minimal oxygen saturation flow limitation snoring before and after therapy in a 3-month interval An orthodontic and craniofacial assessment the examination of orofacial functions and tonguelip strength measurements IOPI system as well as quality of life questionnaires OSA-18 are also performed on participants before and after therapy
Aim Myofunctional therapy has been shown to reduce Apnea-Hyponea indexes AHI of children and can serve as an adjunct to other therapies but the level of compliance is a limiting factor The investigators aim is to evaluate the effectiveness of Passive Oral Myofunctional Reeducation a flexible oral appliance in a group a children scheduled for adeno-tonsillectomy in association with nasal hygiene and to compare them with nasal hygiene alone control group
Methods The design of the study is a randomized Controlled Trial enrolling 60 children with significant obstructive sleep apnea and divided into 2 groups Group 1 using of a flexible oral appliance during quiet activities and sleep nasal hygiene and Group 2 using nasal hygiene alone control group The objective assessment of sleep parameters is performed at home using an ambulatory device AHI desaturation index minimal oxygen saturation flow limitation snoring before and after therapy in a 3-month interval An orthodontic and craniofacial assessment the examination of orofacial functions and tonguelip strength measurements IOPI system as well as quality of life questionnaires OSA-18 are also performed on participants before and after therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None