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NCT05508971 · ClinicalTrials.gov registry record · NA
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
A NA study of Obstructive Sleep Apnea and Down Syndrome, sponsored by Oregon Health and Science University.
- Recruiting
- Registry status
- NA
- Development phase
- 303
- Enrollment target
- 7
- Study locations
NCT05508971 is a NA study of Obstructive Sleep Apnea and Down Syndrome that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 303 participants, above the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (38% higher). The trial reports 7 study locations across 6 states.
The verdict
NCT05508971, a NA study of Obstructive Sleep Apnea and Down Syndrome, is actively recruiting participants, sponsored by Oregon Health and Science University.
- RECRUITING
- Registry status
- NA
- Development phase
- 303 participants
- Enrollment target
- 7
- Study locations
Study Summary
The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. 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. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a
Conditions Studied
Interventions
- PROCEDURE DISE-Directed Surgery
- PROCEDURE Adenotonsillectomy
Study Locations (7)
Texas
- UT Southwestern Medical Center - Dallas
- Texas Children's Hospital - Houston
Colorado
- Colorado Children's Hospital - Aurora
Michigan
- University of Michigan - Ann Arbor
Ohio
- Cincinnati Children's Hospital - Cincinnati
Oregon
- Oregon Health and Science University - Portland
Virginia
- EVMS Medical School - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2023-08-02 |
| Est. Completion | 2028-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05508971
The ClinicalTrials.gov registry entry for NCT05508971 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (38% higher). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which DISE-Directed Surgery is the first listed.
NCT05508971 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Texas, Colorado, Michigan.
Frequently Asked Questions
What is clinical trial NCT05508971 about?
NCT05508971 is a clinical study titled "Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)". The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in t...
What is the current status of trial NCT05508971?
This trial is currently recruiting. It is a NA study. The enrollment target is 303 participants. The study started on 2023-08-02. Estimated completion is 2028-06-30.
What conditions does trial NCT05508971 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT05508971?
The interventions under investigation include: DISE-Directed Surgery (PROCEDURE), Adenotonsillectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05508971?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05508971 being conducted?
This trial has 7 study locations across Colorado, Michigan, Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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