Figures
- FIGURE 1
Changes in apnoea/hypopnoea index (AHI) from baseline to post-titration and final visit results. Data are presented as mean+sd.
- FIGURE 2
Changes in Epworth sleepiness scale (ESS) from baseline to post-titration and final visit results. Data are presented as mean+sd
- FIGURE 3
Clinical Global Impression of the Intervention – Improvement (CGI-I) rated by the physician at post-titration and final visit.
- FIGURE 4
Patient experience with upper airway stimulation (UAS) at the post-titration and final visits. CPAP: continuous positive airway pressure.
Tables
- TABLE 1
Baseline characteristics of the registry participants
Subjects n 508 Age years 59.4±11.2 Sex Male 399 (79) Female 109 (21) Race Caucasian 491 (97) Other 7 (1) Black 6 (1) Asian 2 (<1) American Indian or Alaska Native 2 (<1) BMI kg·m−2 29.3±3.9 Systolic blood pressure mmHg 130±13 Diastolic blood pressure mmHg 78±9 AHI events·h−1 36.3±15.7 ESS 11.8±5.5 Hypertension 46.5 Depression 21.3 Diabetes mellitus 11.2 Atrial fibrillation 5.4 Myocardial infarction 3.8 Stroke 2.5 Data are presented as mean±sd, n (%) or %, unless otherwise stated. BMI: body mass index; AHI: apnoea/hypopnoea index; ESS: Epworth sleepiness scale.
- TABLE 2
Summary of post-operative adverse events
Post-titration Final visit Events
nPatients % Events
nPatients % Tongue weakness 2 <1 0 Swallowing or speech related 3 <1 0 Discomfort (incision/scar) 5 1 5 2 Discomfort (device) 7 2 3 1 Infection 0 0 Post-operative – other# 8 2 3 1 Stimulation-related discomfort 26 8 15 6 Tongue abrasion 7 2 7 3 Insomnia/arousal 6 2 9 3 Revision interventions (including explant) 0 1 <1 Other discomfort 5 1 2 <1 Activation – other 18 5 16 6 Total 87 23 61 23 72 patients reported adverse events at the post-titration visit and 50 at the final visit (not mutually exclusive). Some patients reported multiple adverse events. Percentage of patients was calculated based on the number of patients at each visit who completed the visit form, which contains adverse event information. #: includes shortness of breath, seroma, numbness of the throat and hoarseness during the day and a mild tongue-base and epiglottic obstruction.
- TABLE 3
Logistic regression univariate analysis of predictors of obstructive sleep apnoea treatment success at the final visit (median time 373 days)
OR (95% CI) p-value Age (baseline) years 1.04 (1.01–1.08) 0.01 Sex (female versus male) 2.62 (0.88–7.78) 0.08 BMI (baseline) kg·m−2 0.91 (0.83–0.99) 0.03 AHI (baseline) events·h−1 1.00 (0.98–1.03) 0.88 Therapy hours per week at post-titration visit 1.04 (0.99–1.67) 0.25 Therapy hours per week at final visit 1.02 (0.99–1.04) 0.22 Bilateral protrusion versus right protrusion 2.08 (0.96–4.51) 0.37 Other versus right protrusion 2.03 (0.50–8.21) 0.61 A multivariable model was fit with stepwise selection used to reduce the model to retain only significant parameters (age and body mass index (BMI)) and only age was retained. AHI: apnoea/hypopnoea index.
- TABLE 4
Logistic regression of univariate analysis to assess for predictors of upper airway stimulation adherence (≥28 h per week) at the final visit
Univariable results OR (95% CI) p-value Age at consent 1.04 (1.01–1.07) 0.01 Sex (female versus male) 2.14(0.79–5.77) 0.14 BMI at baseline 0.90 (0.83–0.97) 0.009 Baseline AHI 0.98 (0.96–0.999) 0.04 Bilateral protrusion versus right protrusion 0.92 (0.41–2.11) 0.59 Other versus right protrusion 1.33 (0.32–5.59) 0.62 Change in AHI at post-titration visit 1.01 (0.99–1.04) 0.19 Change in ESS at post-titration visit 0.98 (0.91–1.05) 0.57 AHI success at post-titration visit 0.99 (0.42–2.34) 0.98 Improvement by CGI at post-titration visit 0.67 (0.30–1.51) 0.33 Patient satisfied or strongly satisfied at post-titration 0.60 (0.15–2.47) 0.48 Therapy use at post-titration 1.08 (1.05–1.11) <0.0001 Therapy use ≥28 h per week at post-titration 0.19 (0.07–0.48) 0.0004 A multivariable model was fit with stepwise selection used to reduce the model to retain only significant parameters (age, body mass index (BMI), apnoea/hypopnoea index (AHI) and therapy at post-titration) and only BMI and therapy use at post-titration visit was retained. ESS: Epworth sleepiness scale; CGI: Clinical Global Impressions scale.
Supplementary Material
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Supplementary tables ERJ-01405-2018_Supplement
