Treatment of obstructive sleep apnea with personalized surgery in children with down syndrome (tops-DS)
Active Project Grant Awarded Last action
- Award ID
- R33HL165345
- Recipient
-
Oregon Health & Science University UEI NPSNT86JKN51
- Awarding agency
-
National Heart Lung and Blood Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $1,265,140
Award facts
- Assistance listing
- 93.310 Trans-NIH Research Support
- Completion date 69% complete
- Funding agency
- Office of the Director National Institutes of Health, Department of Health and Human Services
- Place of performance
- Oregon, USA
Award details come from USAspending.gov.
Description
- Abstract
- The overall objective of this randomized clinical trial is to test the effectiveness of a novel 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 down syndrome (DS) ranges from 31-79%, compared to 1-5% in the general pediatric population. Adenotonsillectomy (at) is the first line treatment for OSA in children, however, most studies of at outcomes have excluded children with DS. Limited available evidence demonstrates that 50 to 90% of children with DS have persistent OSA after at. Hypotonia and unfavorable craniofacial anatomy are commonly cited risk factors for failure of at, however, there have been few attempts to characterize the pharyngeal anatomy or mechanisms of obstruction in this population. 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. Several small case series demonstrate that personalized dise-directed surgery can be effective in treating OSA in children with DS. Because there have been few prospective studies and no randomized trials comparing different treatment options, there remains uncertainty about the most effective treatment for OSA in children with DS. IT is our central hypothesis that a personalized dise-directed surgical approach in children with DS will be superior to the recommended first line treatment of at. To test this hypothesis, we propose an unprecedented randomized controlled trial of dise-directed surgery VS at in children with down syndrome ages 2-18 years with the following specific aims: aim 1: compare the physiological outcomes of dise-directed surgery VS at in children with DS. Hypothesis 1: dise-directed surgery will result in a greater improvement in the obstructive apnea-hypopnea index (oahi) compared to the standard at intervention after 6 months. Aim 2: compare the clinical outcomes of dise-directed surgery VS at in children with DS. Hypothesis 2: dise-directed surgery will result in a clinically significantly greater improvement in disease- specific QOL (OSA18) compared to the standard at intervention after 6 months. This comparative effectiveness trial will be the first to directly compare a personalized surgical approach to the standard treatment in children with DS this novel approach may improve OSA outcomes and reduce the burden of unnecessary at or secondary surgery for persistent OSA after an ineffective at.
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Baylor College Of Medicine | $151,809 | |
| The University Of Texas Southwestern Medical Center | $174,945 | |
| Regents Of The University Of Michigan | $157,372 | |
| Old Dominion University | $134,868 |
Quick answers
Who received award R33HL165345?
R33HL165345 was awarded to Oregon Health & Science University by National Heart Lung and Blood Institute (National Institutes of Health) on September 7, 2022.
How much is award R33HL165345 worth?
$1,265,140 has been obligated on R33HL165345.
Which agency awarded R33HL165345?
National Heart Lung and Blood Institute (National Institutes of Health) awarded R33HL165345, with funding from Office of the Director (National Institutes of Health).
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