Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258837
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-06
Brief Title:
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Small Tonsils
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPS-ST
Brief Summary:
The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils ST This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months It is the investigators central hypothesis that a personalized drug-induced sleep endoscopy DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction ie anatomic endotypes in each child with ST will perform better than the currently recommended standard first line approach of AT This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT To test this hypothesis the investigators propose to study children aged 2-17 years with small tonsils and OSA
Detailed Description:
Obstructive sleep apnea OSA is common in children with an estimated prevalence of 1-6 Untreated pediatric OSA is associated with hypertension autonomic dysfunction attention-deficit hyperactivity disorder neurocognitive deficits poor school performance poor quality of life and a 200 increase in health care utilization compared to controls Adenotonsillar hypertrophy is the primary risk factor for pediatric OSA and adenotonsillectomy AT is the recommended first line treatment However the prevalence of persistent OSA after AT has been reported to be at least 20 among children with large tonsils indicating that AT may not be the optimal intervention in all cases Although the prevalence of small tonsils in children with OSA symptoms is up to 70 there is currently no clear evidence on the outcome of AT in children with small tonsils It has been shown that clinic assessments of tonsil size do not correlate with OSA severity or response to AT leaving confusion about how best to treat OSA in children with small tonsils This knowledge gap represents an opportunity to apply a personalized treatment approach and improve outcomes
DISE entails passage of a flexible endoscope through the nose into the pharynx and enables direct observation of the sites and patterns of upper airway obstruction during sedated sleep DISE was developed to guide surgical decisions in adult OSA and in recent years has also been used to design personalized surgical interventions in children To help standardize DISE assessments the investigators previously developed and validated the DISE Rating Scale in children based on ordinal ratings of maximal airway obstruction none partial complete at six anatomic sites from the nose to the larynx
The investigators also demonstrated that DISE ratings of adenotonsillar obstruction during sedated sleep are strongly associated with both OSA severity and response to AT unlike clinic assessments of tonsil size The investigators preliminary data and other published studies have identified a high prevalence of non-adenotonsillar obstruction that can occur at the nose palate base of tongue and larynx Surgery that is tailored to the specific anatomic sites of obstruction observed during DISE may improve pediatric OSA outcomes but existing studies are small uncontrolled case series in heterogeneous study populations There are no trials directly comparing AT and DISE-directed surgery in the common scenario of surgically naïve children with small tonsils
The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils ST This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months It is the investigators central hypothesis that a personalized drug-induced sleep endoscopy DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction ie anatomic endotypes in each child with ST will perform better than the currently recommended standard first line approach of AT This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT To test this hypothesis the investigators propose to study children aged 2-17 years with small tonsils and OSA
DISE entails passage of a flexible endoscope through the nose into the pharynx and enables direct observation of the sites and patterns of upper airway obstruction during sedated sleep DISE was developed to guide surgical decisions in adult OSA and in recent years has also been used to design personalized surgical interventions in children To help standardize DISE assessments the investigators previously developed and validated the DISE Rating Scale in children based on ordinal ratings of maximal airway obstruction none partial complete at six anatomic sites from the nose to the larynx
The investigators also demonstrated that DISE ratings of adenotonsillar obstruction during sedated sleep are strongly associated with both OSA severity and response to AT unlike clinic assessments of tonsil size The investigators preliminary data and other published studies have identified a high prevalence of non-adenotonsillar obstruction that can occur at the nose palate base of tongue and larynx Surgery that is tailored to the specific anatomic sites of obstruction observed during DISE may improve pediatric OSA outcomes but existing studies are small uncontrolled case series in heterogeneous study populations There are no trials directly comparing AT and DISE-directed surgery in the common scenario of surgically naïve children with small tonsils
The purpose of this study is to compare the effectiveness of a novel personalized surgical approach to the standard AT in children with small tonsils ST This will be accomplished by randomizing children with ST and OSA to one of these two treatments and comparing outcomes after 6 months It is the investigators central hypothesis that a personalized drug-induced sleep endoscopy DISE-directed surgical approach that uses existing procedures to address the specific fixed and dynamic anatomic features causing obstruction ie anatomic endotypes in each child with ST will perform better than the currently recommended standard first line approach of AT This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT To test this hypothesis the investigators propose to study children aged 2-17 years with small tonsils and OSA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None