Sleep Disorders

Hypoglossal Nerve Stimulation and Patient-Reported Outcomes

2020 – 2021

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

Hypoglossal nerve stimulation (HNS) has been shown to improve patient-reported outcomes (PROs) in obstructive sleep apnea (OSA).

23 OSA patients treated with HNS had at least 2 visits from 2020–2021 with ESS data available for analysis. Among those patients whose baseline ESS score ≥ 10 (N = 9), 44.4% (N = 4) showed improvement, 22.2% (N = 2) remained stable, and 33.3% (N = 3) worsened. Median duration of follow-up was 441 days (range, 56-615). Clinically meaningful change was defined as a total point change of 3, based on one-half the standard deviation.¹

32 OSA patients treated with HNS had at least 2 visits from 2020–2021 with PHQ-9 data available for analysis. Among those patients whose baseline PHQ-9 score ≥ 10 (N = 7), 42.9% (N = 3) showed improvement, 42.9% (N = 3) remained stable, and 14.3% (N = 1) worsened. Median duration of follow-up was 308 days (range, 56-550). Clinically meaningful change was defined as a total point change of 5.²

34 OSA patients treated with HNS had at least 2 visits from 2020–2021 with PROMIS Mental Health data available for analysis. Among those patients whose baseline PROMIS Mental Health score ≤ 45 (N = 14), 14.3% (N = 2) showed improvement, 71.4% (N = 10) remained stable, and 14.3% (N = 2) worsened. Median duration of follow-up was 321 days (range, 95-555). Clinically meaningful change was defined as a 5-point change in T-score, based on one-half the standard deviation.¹

33 OSA patients treated with HNS had at least 2 visits from 2020–2021 with PROMIS Physical Health data available for analysis. Among those patients whose baseline PROMIS Physical Health score ≤ 45 (N = 11), 27.3% (N = 3) showed improvement, 45.5% (N = 5) remained stable, and 27.3% (N = 3) worsened. Median duration of follow-up was 273 days (range, 95-584). Clinically meaningful change was defined as a 5-point change in T-score, based on one-half the standard deviation.¹

24 OSA patients treated with HNS had at least 2 visits from 2020–2021 with Sleep Time data available for analysis. Among those patients whose baseline Sleep Time ≤ 24 hours (N = 24), 29.2% (N = 7) showed improvement, 54.2% (N = 13) remained stable, and 16.7% (N = 4) worsened. Median duration of follow-up was 290 days (range, 187-644). Clinically meaningful change was defined as a 1 hour change, based on one-half the standard deviation.¹

32 OSA patients treated with HNS had at least 2 visits from 2020–2021 with PROMIS Sleep Disturbance data available for analysis. Among those patients whose baseline PROMIS Sleep Disturbance score ≥ 55 (N = 13), 53.8% (N = 7) showed improvement, 46.2% (N = 6) remained stable, and 0% (N = 0) worsened. Median duration of follow-up was 308 days (range, 56-671). Clinically meaningful change was defined as a 5-point change in T-score, 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.