Sleep Disorders

Hypoglossal Nerve Stimulation and Patient-Reported Outcomes

2020 – 2021

Hypoglossal Nerve Stimulation and Patient-Reported Outcomes

2021 - 2022

ESS = Epworth Sleepiness Scale, HNS = Hypoglossal Nerve Stimulation, PHQ-9 = Patient Health Questionnaire, PROMIS = Patient-Reported Outcomes Measurement Information System

37 OSA patients treated with HNS had at least 2 visits from 2021–2022 with ESS data available for analysis. Among those patients whose baseline ESS score ≥ 10 (N = 16), 37.5% (N = 6) improved, 37.5% (N = 6) remained stable, and 25% (N = 4) worsened. Median duration of follow-up was 150 days (range, 34-556 days). Clinically meaningful change was defined as a total score change of 3, based on one-half the standard deviation.¹

43 OSA patients treated with HNS had at least 2 visits from 2021–2022 with PHQ-9 data available for analysis. Among those patients whose baseline PHQ-9 score ≥ 10 (N = 10), 20% (N = 2) improved, 60% (N = 6) remained stable, and 20% (N = 2) worsened. Median duration of follow-up was 145 days (range, 56-478 days). Clinically meaningful change was defined as a total score change of 5.²

40 OSA patients treated with HNS had at least 2 visits from 2021–2022 with PROMIS Mental Health data available for analysis. Among those patients whose baseline PROMIS Mental Health score ≤ 45 (N = 10), 10% (N = 1) improved, 90% (N = 9) remained stable, and 0% (N = 0) worsened. Median duration of follow-up was 227 days (range, 76-677 days). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹

41 OSA patients treated with HNS had at least 2 visits from 2021–2022 with PROMIS Physical Health data available for analysis. Among those patients whose baseline PROMIS Physical Health score ≤ 45 (N = 19), 26.3% (N = 5) improved, 47.4% (N = 9) remained stable, and 26.3% (N = 5) worsened. Median duration of follow-up was 230 days (range, 30-640 days). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹

42 OSA patients treated with HNS had at least 2 visits from 2021–2022 with PROMIS Sleep Disturbance data available for analysis. Among those patients whose baseline PROMIS Sleep Disturbance score ≥ 55 (N = 18), 44.4% (N = 8) improved, 38.9% (N = 7) remained stable, and 16.7% (N = 3) worsened. Median duration of follow-up was 187 days (range, 28-556 days). Clinically meaningful change was defined as a 5-unit change in T-score, based on one-half the standard deviation.¹

19 OSA patients treated with HNS had at least 2 visits from 2021–2022 with Sleep Time data available for analysis. Among those patients whose baseline Sleep Time ≤ 24 hours (N = 19), 26.3% (N = 5) improved, 57.9% (N = 11) remained stable, and 15.8% (N = 3) worsened. Median duration of follow-up was 308 days (range, 189-556 days). Clinically meaningful change was defined as a 1-hour change, based on one-half the standard deviation.¹

References
  1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-592.
  2. Löwe B, Unützer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the Patient Health Questionnaire-9. Med Care. 2004 Dec;42(12):1194-1201.