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Sleep Medicine

(429) Response of Epworth Sleepiness Scale Dimensions to Hypoglossal Nerve Stimulation

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time
Has Audio

    Presenting Author(s)

  • OJ

    Ofer Jacobowitz, MD, PhD

    Director of Sleep
    ENT and Allergy Associates- New York, NY
    New York, New York, United States

    • Co-Author(s)

  • EL

    Eric Lovett, PhD

    Clinical and Medical Affairs
    Livanova
    Mendota Heights, Minnesota, United States

  • AM

    Atul Malhotra, MD

    University of California San Diego, La Jolla, California, USA

  • Joachim T. Maurer, MD

    Professor
    Universitätsmedizin Mannheim
    Mannheim, Baden-Wurttemberg, Germany

  • SM

    Samuel A. Mickelson, MD

    Director of Atlanta Snoring and Sleep Disorders Institute
    Advanced ENT & Allergy
    Atlanta, Georgia, United States

  • AS

    Alan R. Schwartz, MD

    Adjunct Professor; Part-time faculty
    University of Pennsylvania
    BALTIMORE, Maryland, United States

Disclosure(s):
Ofer Jacobowitz, MD, PhD: No relevant relationships to disclose.
Eric Lovett, PhD: No relevant relationships to disclose.
Joachim T. Maurer, MD: No relevant relationships to disclose.
Samuel A. Mickelson, MD: No relevant relationships to disclose.
Alan R. Schwartz, MD: No relevant relationships to disclose.


Introduction: Hypoglossal nerve stimulation (HGNS) trials report large effect sizes for the Epworth Sleepiness Scale (ESS), but individual item responsiveness to HGNS is unexplored. Therefore, HGNS effect sizes for individual ESS items were quantified for the THN3 randomized, controlled trial of moderate to severe obstructive sleep apnea.

Methods: ESS responses were analyzed for THN3 participants with complete data through 11 months of proximal HGNS treatment. Summary statistics and effect sizes for ESS dimensions were computed using standardized mean difference and probability of superiority for improvement relative to Baseline.
ESS vignettes 1-8 can be summarized as “Sitting and reading,” “Watching TV,” “Sitting inactive in a public place,” “As a passenger in a car for an hour…,” “Lying down to rest in the afternoon…,” “Sitting and talking to someone,” “Sitting quietly after a lunch…,” and “In a car, while stopped for a few minutes...”, rated on a scale of 0-3.

Results: Complete data were available for 125/138 (91%) of participants, except for vignette 3 (N=121). Total ESS and each individual component improved significantly. Total ESS declined from 11.4±4.8 at Baseline to 6.6±4.5 after 11 months of HGNS, mean±SD, with standardized mean difference -1.20 and probability of superiority 0.86. Baseline ESS components 1-8 were, respectively, 1.9±0.94, 1.9±0.90, 1.3±0.95, 1.6±1.02, 2.5±0.84, 0.4±0.63, 1.3±0.97, and 0.5±0.67. Standardized mean differences post-11 months HGNS were -0.89, -0.85, -0.82, -0.84, -0.66, -0.52, -0.64, and -0.38. Likewise, probabilities of superiority were 0.76, 0.77, 0.73, 0.75, 0.72, 0.62, 0.71, and 0.60.

Conclusions: Subjective sleepiness improvement occurred with HGNS treatment for all ESS components, generally with larger responses for items with higher baseline severity.