To Örebro University

PURPOSE: Although overall success rates for treating obstructive sleep apnea (OSA) with an oral appliance (OA) are high, they are significantly higher among females. To verify published data, the study's purpose was to evaluate a participant sample after one year of OA use. The primary outcome was treatment response, with responders defined as having an apnea-hypopnea index (AHI) < 10 at follow-up and/or reduced by ≥50% of baseline. Secondary measures were from standardized questionnaires.

METHODS: A sample of 314 participants, predominately with moderate-to-severe OSA, were enrolled and instructed to use an OA every night. At baseline and one-year follow-up, polygraphic recordings and questionnaires, including sleepiness (measured using the Epworth sleepiness scale) and quality-of-life (measured using the Functional Outcomes of Sleep Questionnaire), were collected.

RESULTS: Among the 314 participants, 192 completed the one-year evaluation: 51 females (27%) and 141 males (73%). Overall, OA treatment resulted in 78% and 77% responders among females and males, respectively. Neither the difference in improvement nor the absolute change in AHI differed significantly based on gender, at any OSA severity level. There were no significant gender differences in sleepiness or quality of life. Treatment-related adverse reactions were more common among females.

CONCLUSION: Both females and males with OSA respond well to OA therapy, with nonsignificant gender differences in outcomes. Thus, the hypothesis that females respond better to OA treatment is rejected.

INTRODUCTION: This multicenter trial on patients with obstructive sleep apnea (OSA) treated with an oral appliance aimed to determine the effect of sleeping positions.

METHODS: A cohort of 314 patients with OSA were enrolled and evaluated at 8 weeks and 1 year, focusing on treatment effects. At baseline and the 2 follow-ups, new polygraphic registration comparing the proportion of treatment responders without position-dependent OSA (non-position-dependent OSA [non-POSA]) and with POSA was used.

RESULTS: At the 8-week and 1-year follow-up, 205 and 139 patients were included, respectively. The proportion of responders (apnea-hypopnea index [AHI] <10 and/or ≥50% reduction in AHI) was 56% for the non-POSA group and 69% for the POSA group (not significant [NS]). The responders increased at the 1-year follow-up: 68% and 77% for the non-POSA and POSA groups (NS), respectively. The absolute change in AHI in all sleeping positions at 8 weeks was -12.9 (interquartile range, -25.0 to -0.5) in the non-POSA group and -10.5 (interquartile range, -19.9 to -5.3; NS) in the POSA group. However, the decrease in supine AHI was significantly greater among subjects with POSA. In contrast, the decrease in nonsupine AHI was significantly greater in the non-POSA group, an effect that remained at the 1-year follow-up.

CONCLUSIONS: Our hypothesis that subjects with POSA at baseline would have a higher treatment response rate after oral appliance treatment compared with subjects without POSA was rejected. However, those with POSA had a significantly higher supine AHI decrease, and those without POSA had significantly less nonsupine AHI.

Introduction: This 10-year prospective cephalometric study evaluates the influence of a mandibular protruding device (MPD) in people with obstructive sleep apnea and snoring.

Methods: A baseline study population of 77 people was followed biennially. After 10 years, 65 people (45 MPD users and 20 stopped-MPD users) were reexamined. At baseline and after 10 years, a lateral cephalogram was taken in the upright position.

Results: MPD users showed significant changes in all cephalometric variables except for maxillary protrusion. The maxillary incisors were retroclined by a mean -4.2 degrees (standard deviation [SD] 3.95; P <0.001), mandibular incisors were proclined by a mean 3.2 degrees (SD, 5.02; P <0.001), and SNB was reduced by a mean -0.6 degrees (SD 1.41; P = 0.01). In those who had stopped MPD use, these initial cephalometric values were retained. Significant changes in decreased overjet and overbite were seen in the MPD group but not in the MPD-stopped group. The length of the mandible (Cd-Pg) increased by a mean of 5.1 mm (SD 6.78; P <0.001) and 6.1 mm (SD 5.99; P <0.001) in MPD and MPD-stopped groups, respectively. The hyoid bone-mandibular plane distance (hy-ML) increased by a mean of 3.3 mm (SD, 2.90; P <0.001) and 3.8 mm (SD 3.67; P = 0.001) in MPD and MPD-stopped groups, respectively.

Conclusions: Long-term nocturnal MPD use causes retroclination of the maxillary incisors and proclination of the mandibular incisors with consequent decreased overjet and overbite. Both MPD and MPD-stopped users obtained increased mandibular length and lower position of the hyoid bone, which can be a normal physiological change with age.

Objective: The benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances would be equally effective.

Material and methods: In this multicentre, randomized equivalence trial, patients with OSA received one type of bibloc or one type of monobloc treatment. At baseline, a 1-night polygraphy study was done, and this was repeated after 1 year. The outcome was any change in the apnoea-hypopnoea index (AHI) and the limits of equivalence between the two devices were set at ±5 AHI units.

Results: Of 302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances. In 88 and 104 patients, respectively, there were significant reductions in the AHI (p < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups. The proportions of responders defined as having an AHI <10 were 68% and 65% for the bibloc and monobloc groups, respectively. Treatment-related adverse events were mild, transient and the dropouts were more frequent in the bibloc group.

Conclusions: Both types of treatments positively and significantly reduced respiratory disturbances, but at the 1-year follow-up, they were not significantly different in treating OSA, with a numerically greater reduction of the AHI value with the bibloc appliance. However, the higher proportion of treatment-related adverse events and higher proportion of dropouts among bibloc users should be balanced against the advantage of a greater reduction in the AHI.

Background: The benefit of bibloc over monobloc appliances in one-year obstructive sleep apnea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances are equally effective.

Methods: In this multicenter, randomized equivalence trial patients with OSA were assigned to either bibloc or monobloc appliance treatment. At baseline a one-night home respiratory polygraphy was done without respiratory support, and at one-year follow-up examination iterated with the appliance in place. The outcome was the change in the apnea-hypopnea-index (AHI) and the equivalence limits were set at ±5.

Results: Out of 302 patients 146 were randomly assigned to bibloc and 156 to monobloc. In 88 and 104 patients, respectively, were analysed per-protocol with a significant reduction of AHI with a mean change -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc and not significantly equivalent. The proportion of responders defined as AHI < 10 at the follow-up was 68% and 65% for bibloc and monobloc, respectively. Treatment related adverse events were generally mild and transient and occurred similar in frequencies between groups.

Conclusions: Bibloc and monobloc appliance treatment gave a significant positive effect in treating OSA. The treatment modalities were not statistically equivalent, with a numerically greater reduction with bibloc, and, were associated with a similar degree of adverse events.

Background: The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA.

Objective: To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective.

Patients and methods: In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy.

Results: Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively).

Limitations: The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive.

Conclusion: In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude.

Trial registration: Registered with ClinicalTrials.gov (#NCT02148510).