Supplementary Online Content Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral appliance therapy in patients with daytime sleepiness and snoring or mild to moderate sleep apnea: a randomized clinical trial [published online June 1, 2015]. JAMA. doi:10.1001/jamainternmed.2015.2051. efigure 1. The oral appliance (upper) and the placebo device covering the palate (lower) efigure 2. Flow chart of the recruitment procedure and the studied sample efigure 3. Proportion of subjects suffering from various types of headache with the oral appliance and the placebo device at baseline (left) and at follow-up (right) efigure 4. Side-effects of the devices VAS = Visual analog scale etable 1. Reasons for exclusion etable 2. Quality of life assessed in the 36-item Short-Form health survey (SF-36) with the oral appliance (n=45) and the placebo device (n=46) in patients with mild to moderate sleepdisordered breathing etable 3. Quality of life assessed in the Functional Outcomes of Sleep Questionnaire (FOSQ) with the oral appliance (n=45) and the placebo device (n=46) in patients with mild to moderate sleep-disordered breathing This supplementary material has been provided by the authors to give readers additional information about their work. 2015 American Medical Association. All rights reserved.
efigure 1. The oral appliance (upper) and the placebo device covering the palate (lower) 2015 American Medical Association. All rights reserved.
efigure2. Enrolment Investigated at the sleep laboratory (n=1,247) Referred to dentist and assessed for eligibility (n=537) Excluded (n=441) Included and randomized (n=96) Allocation Oral appliance group (n=48) Received allocated intervention (n=48) Placebo group (n=48) Received allocated intervention (n=48) ) Four-month follow-up Discontinued (n=3) Did not tolerate (n=2), refused follow-up (n=1) Analyzed (n=45) Discontinued (n=2) Lack of subjective treatment effect (n=2) Analyzed (n=46) Flow chart of the recruitment procedure and the studied sample 2015 American Medical Association. All rights reserved.
efigure 3. Proportion of subjects suffering from various types of headache with the oral appliance and the placebo device at baseline (left) and at follow-up (right) 2015 American Medical Association. All rights reserved.
efigure 4. Side-effects of the devices VAS = Visual analog scale
etable 1. Reasons for exclusion Investigated at sleep lab (n=710) Severe OSA 301 BMI 35 48 < 20 yrs or 70 yrs of age 26 Other diseases 70 Professional driver 15 Refused participation 46 Other causes 204 Excluded at dentist (n=441) Severe OSA 27 BMI 35 20 < 20 yrs. or 70 yrs. of age 22 Not sleepy 69 Diseases 8 Large tonsils 7 Professional driver 28 Refused participation 71 Poor dental health 17 Small protrusion 10 Few teeth 4 Craniomandibular symptoms 6 CPAP treatment 58 OSA surgery 6 MAD treatment 27 No treatment needed 18 Included in other studies 2 Old sleep recording 4 Biased to the study 14 Long distance to the clinic 23
etable 2. Quality of life assessed in the 36-item Short-Form health survey (SF-36) with the oral appliance (n=45) and the placebo device (n=46) in sleepy patients with snoring or mild and moderate sleep apnea Physical Functioning OA Baseline OA 4 mo Placebo Baseline Placebo 4 mo Placebo-OA Mean (95%CI) 87.6 (13.6) 90.7 (12.6) 87.8 (14.1) 86.7 (14.6) -4.0 (-9.7-1.7) Role Physical 67.8 (39.0) 78.3 (36.8) 71.9 (35.8) 73.9 (38.1) -4.5 (-20.3-11.3) Bodily Pain 64.5 (22.2) 69.7 (24.6) 63.6 (21.9) 65.4 (21.0) -4.3 (-13.9-5.3) General Health 62.3 (22.8) 67.3 (24.2) 63.7 (21.6) 63.2 (21.1) -4.2 (-13.9-5.6) Vitality 46.6 (19.3) 61.6 (18.6) 45.0 (23.3) 53.0 (25.3) -8.6 (-18.0-0.8) Social Functioning 74.2 (23.8) 85.6 (21.8) 79.1 (23.6) 84.1 (23.7) -1.5 (-11.1-8.1) Role Emotional 80.0 (35.1) 83.7 (31.5) 86.4 (28.1) 81.8 (34.8) -1.9 (-15.9-12.1) Mental Health 74.8 (14.6) 79.8 (14.4) 76.4 (16.2) 78.7 (16.3) -1.1 (-7.6-5.5) Physical Health Score Mental Health Score 45.9 (8.9) 48.2 (8.4) 45.3 (8.5) 46.0 (10.3) -2.2 (-6.3-1.8) 44.3 (10.8) 48.1 (9.7) 46.1 (10.5) 47.2 (12.1) -0.9 (-5.6-3.8
etable 3. Quality of life assessed in the Functional Outcomes of Sleep Questionnaire (FOSQ) with the oral appliance (n=45) and the placebo device (n=46) in sleepy patients with snoring or mild and moderate sleep apnea General Productivity OA Baseline OA 4 mo Placebo Baseline Placebo 4 mo Placebo-OA Mean (95%CI) 3.5 (0.4) 3.7 (0.5) 3.5 (0.5) 3.5 (0.6) -0.2 (-0.4-0.1) Social Outcome 3.6 (0.6) 3.7 (0.6) 3.5 (0.7) 3.5 (0.8) -0.2 (-0.5-0.1) Activity Level 3.0 (0.6) 3.4 (0.5) 3.1 (0.7) 3.2 (0.7) -0.2 (-0.5-0.1) Vigilance 3.0 (0.7) 3.4 (0.5) 3.1 (0.6) 3.2 (0.8) -0.2 (-0.5-0.1) Intimate Relationships 3.1 (0.8) 3.5 (0.7) 3.1 (0.9) 3.1 (1.0) -0.2 (-0.5-0.1) Mean Score 3.2 (0.5) 3.5 (0.5) 3.3 (0.5) 3.3 (0.7) -0.3 (-0.5-0.0) Total Score 16.1 (2.3) 17.6 (2.3) 16.3 (2.6) 16.4 (3.4) -1.2 (-2.5-0.1)