Table 1

Baseline demographics and clinical characteristics (tolerance and per-protocol populations)

Tolerance populationPer-protocol population
TALI
(N=98)
ONIRIS
(N=92)
TALI
(N=87)
ONIRIS
(N=69)
Age (years)52.9 (12.3 ; n=98)49.0 (11.60 ; n=92)52.9 (12.2 ; n=87)49.3 (11.2 ; n=69)
Gender
  • Men

75 (76.5%)63 (68.5%)67 (77%)50 (72.5%)
  • Women

23 (23.5%)29 (31.5%)20 (23%)19 (27.5%)
Body mass index (kg/m²)26.12 (2.80 ; n=98)25.77 (2.70 ; n=91)25.91 (2.85 ; n=87)25.86 (2.71 ; n=68)
MAD indication
  • Initial CPAP refusal

41 (41.8%)39 (42.4%)33 (37.9%)29 (42%)
  • Not tolerating CPAP

57 (58.2%)52 (56.5%)54 (62.1%)39 (56.5%)
AHI per hour27.4 (10.1 ; n=98)26.0 (10.7 ; n=92)27.1 (9.8 ; n=87)26.1 (11.1 ; n=69)
Systolic blood pressure128.0 (19.5 ; n=97)126.3 (14.4 ; n=92)127.6 (19.9 ; n=87)126.4 (13.7 ; n=69)
Diastolic blood pressure81.0 (12.1 ; n=97)81.3 (11.3 ; n=92)81.3 (12.3 ; n=87)81.8 (11.4 ; n=69)
Hypertension (WHO criteria)
  • Mild

20 (20.6%)21 (22.8%)18 (20.7%)15 (21.7%)
  • Moderate

7 (7.2%)5 (5.4%)6 (6.9%)4 (5.8%)
  • No hypertension

70 (72.2%)66 (71.7%)63 (72.4%)50 (72.5%)
Snoring (10 cm on VAS)6.402 (2.259 ; n=94)6.675 (2.371 ; n=86)6.420 (2.203 ; n=84)6.654 (2.460 ; n=65)
Number of missing teeth3.9 (3.2 ; n=98)3.4 (2.4 ; n=92)3.8 (3.2 ; n=87)3.4 (2.5 ; n=69)
Partially edentulous patient
  • At least one missing tooth

83 (83.9%)75 (81.2%)73 (84.7%)56 (81.5%)
  • At least four missing teeth

56 (57.1%)50 (54.4%)49 (56.3%)37 (53.6%)
  • Data are n (%) or mean (SD; number of patients), unless otherwise indicated. The tolerance population was defined as all randomised patients who used the device at least once. The per-protocol population was defined as all randomised patients who used the device at least once with no major deviation regarding the established protocol such as non-conformity to major inclusion and exclusion criteria, and no assessment of the primary endpoint at 2-month follow-up visit (except for patients reporting a lack of efficacy in-between visits).

  • AHI, apnoea–hypopnoea index; CPAP, continuous positive airway pressure; MAD, Mandibular advancement device; VAS, visual analogue scale.