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Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome
- Yu, Phoebe K;
- Jayawardena, Asitha DL;
- Stenerson, Matthew;
- Pulsifer, Margaret B;
- Grieco, Julie A;
- Abbeduto, Leonard;
- Dedhia, Raj C;
- Soose, Ryan J;
- Tobey, Allison;
- Raol, Nikhila;
- Ishman, Stacey L;
- Shott, Sally R;
- Cohen, Michael S;
- Skotko, Brian G;
- Kinane, Thomas B;
- Keamy, Donald G;
- Hartnick, Christopher J
- et al.
Published Web Location
https://doi.org/10.1002/lary.29290Abstract
Objectives/hypothesis
Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation.Study design
Prospective longitudinal trial.Methods
We are conducting a multicenter single-arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients.Results
The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA-18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%.Conclusions
Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard.Level of evidence
4 Laryngoscope, 131:1663-1669, 2021.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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