Table 2.
Sleep study (level 3), sleepiness, QOL, and fatigue self-reported data at baseline, after the 2-month treatment, and the amount of change (with statistical analysis of the amount of change between the treatments).
| Efficacy of OA | TSD Users (n = 27) | MAD Users (n = 26) | ΔTSD vs ΔMAD P c (95% CI) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2 Months | ΔTSD | P a (95% CI) | Baseline | 2 Months | ΔMAD | P b (95% CI) | ||
| Objective measures (HSAT) | |||||||||
| REI (events/h) | 17.3 ± 14.3 | 9.0 ± 7.0 | –8.3 ± 12.8 | < .01*,d (2.7–11.7) | 18.0 ± 13.0 | 8.7 ± 6.7 | –8.8 ± 11.0 | < .01*,d (3.0–13.5) | .88d (–4.6 to 5.7) |
| ODI 3% (events/h) | 13.0 ± 13.0 | 6.9 ± 5.5 | –6.1 ± 11.9 | < .01*,d (1.1–10.0) | 15.0 ± 11.0 | 8.0 ± 6.5 | –7.0 ± 8.9 | < .01*,d (2.7–10.1) | .39d (–2.5 to 5.6) |
| Self-reported measures | |||||||||
| ESS score | 8.1 ± 4.8 | 7.2 ± 5.0 | –0.5 ± 2.8 | .67d (–1.0 to 1.5) | 9.8 ± 6.1 | 6.8 ± 4.7 | –2.9 ± 4.3 | < .01*,d (1.5–6.5) | .04*,d (1.3–3.0) |
| SF-36 physical score | 50.2 ± 9.9 | 47.7 ± 11.4 | –2.2 ± 9.5 | .87d (–2.5 to 7.2) | 49.0 ± 8.1 | 52.0 ± 7.0 | 3.0 ± 7.4 | < .02*,d (–5.4 to –0.3) | .07d (–7 to 0.2) |
| SF-36 mental score | 46.9 ± 9.6 | 49.1 ± 8. 0 | 2.2 ± 9.2 | .21d (–6.0 to 1.1) | 46 ± 11 | 50.0 ± 10 | 3.7 ± 11 | .01*,d (–8.2 to –1.0) | .40d (–6.7 to 2.8) |
| FOSQ-10 total score | 15.3 ± 3.0 | 15.6 ± 3.5 | 0.14 ± 2.2 | .51d (–1.2 to 0.6) | 15.0 ± 2.9 | 17.0 ± 3.2 | 1.6 ± 2.4 | < .01*,d (–2.5 to –1.1) | < .01*,d (–2.7 to –0.5) |
| CFQ total score | 15.5 ± 6.6 | 11.6 ± 6.0 | –3.8 ± 5.5 | < .01*,d (1.4–6.1) | 15.0 ± 7.0 | 12.0 ± 5.5 | –2.5 ± 4.4 | .01*,d (1.5–8.0) | .90d (–4.0 to 3.0) |
| CFQ physical fatigue score | 10.4 ± 4.6 | 7.7 ± 4.8 | –2.7 ± 4.1 | .01*,d (1.5–6.0) | 9.7 ± 4.7 | 7.2 ± 3.7 | –2.4 ± 06.2 | .01*,d (1.0–0.0) | .67d (–3.0 to 2.0) |
| CFQ mental fatigue score | 5.1 ± 2.5 | 4.0 ± 2.0 | –1.1 ± 2.2 | .02*,d (0.2–2.0) | 5.6 ± 2.8 | 4.6 ± 2.2 | –1.0 ± 2.4 | .03d (0.2–2.0) | .93d (–1.0 to 1.0) |
All measurements are described as mean ± SD. *Statistically significant at P ≤ .05. a2-month vs baseline within TSD users group. b2-month vs baseline within MAD users’ group. cΔTSD vs ΔMAD. dNonparametric test. CFQ = Chalder Fatigue Scale, CI = confidence interval, ESS = Epworth Sleepiness Scale, FOSQ-10 = Functional Outcomes of Sleep Questionnaire-10, HSAT = home sleep apnea testing, MAD = mandibular advancement device, OA = oral appliance, ODI = oxygen desaturation index, QOL = quality of life, REI = respiratory event index, SD = standard deviation, SF-36 = 36-Item Short-Form Health Survey, TSD = tongue-stabilizing device, Δ = 2-month variable − baseline variable.