0766 Group Trajectories Demonstrate Robust Effects of Targeted Hypoglossal Nerve Stimulation in the THN3 Randomized, Controlled Trial

Abstract Introduction THN3 was the first reported parallel-arm, randomized controlled trial (RCT) of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in patients with moderate to severe OSA and BMI≤35kg/...

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Published in:Sleep (New York, N.Y.) N.Y.), 2022-05, Vol.45 (Supplement_1), p.A333-A334
Main Authors: Schwartz, Alan, Jacobowitz, Ofer, Mickelson, Samuel, Miller, Mitchell, Oliven, Arie, Certal, Victor, Hopp, Martin, Winslow, David, Huntley, Tod, Nachlas, Nathan, Gillespie, M Boyd, Weeks, Brian, Lovett, Eric, Shen, John, Maurer, Joachim
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Language:English
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Summary:Abstract Introduction THN3 was the first reported parallel-arm, randomized controlled trial (RCT) of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. Unique among reported HGNS trials, separate cohorts of patients receiving early and late THN were followed longitudinally. Methods Measurements of apnea-hypopnea index (AHI) were available Pre-enrollment, Baseline (2 nights), Month 4 and Month 12/15. Except for Pre-enrollment, AHI values were calculated by an independent core laboratory from polysomnographic recordings. All subjects with complete data were included for analysis. AHI trajectories were constructed for early and late THN activation (Treatment[T], N=83, Month 1 and Control[C], N=45, Month 4, respectively) by computing median values. Confidence intervals were calculated by bootstrapping each median (N=30,000). Patient-reported outcome measures (PROMs) were treated similarly. Results AHI (Median (95% CI)) trajectories demonstrated a consistent pattern of pre-implant alignment (Pre-enrollment T:39.1 (36.0-45.0), C:38.0 (32.0-41.0); Baseline 1 T:36.1 (33.0-39.9), C:31.3 (27.2-38.6); Baseline 2 T:37.0 (34.3-41.0), C:35.2 (32.3-38.2)), divergence at the conclusion of the randomization period (Month 4 T:15.6 (11.9-25.3), C:30.6 (23.7-38.6)) and reconvergence following 11 months of treatment (Month 12/15 T:20.7 (16.0-26.4), C:18.1 (16.3-23.3)). Non-standardized Pre-enrollment AHI was slightly higher than Baseline values. Trajectories were similar for oxygen desaturation index (Baseline 1 T:35.3 (31.9-38.0),C:34.3 (27.5-40.3); Baseline 2 T:37.1 (33.4-39.3),C:36.8 (33.9-38.3); Month 4 T:19.5 (16.2-28.5), C:33.8 (25.4-41.1); Month 12/15 T:19.5 (16.0-25.6), C:19.7 (16.3-26.0)), the Epworth Sleepiness Scale (Baseline T:11.0 (10.0-13.0),C:11.5 (8.5-14.0); Month 4 T:6.0 (5.0-7.0), C:11.5 (8.0-12.5); Month 12/15 T:6.0 (4.0-7.0), C:5.5 (4.5-6.0)), the Functional Outcomes of Sleep Questionnaire (Baseline T:15.3 (14.0-16.5),C:14.7 (13.3-16.6); Month 4 T:18.3 (17.7-18.8), C:16.7 (14.9-17.7); Month 12/15 T:18.8 (18.3-19.3), C:18.5 (17.5-19.5)) and the Snore Outcomes Survey (Baseline T:26.6 (21.9-31.3),C:21.9 (18.8-31.3); Month 4 T:60.9 (56.3-67.9), C:29.7 (23.4-42.9); Month 12/15 T:62.5 (59.4-68.8), C:68.8 (62.5-71.9)). Conclusion Group trajectories of sleep-disord
ISSN:0161-8105
1550-9109
DOI:10.1093/sleep/zsac079.762