Therefore, we are looking for clinical research centres, i.e. sleep laboratories at (university) hospitals, to perform clinical surveillance studies in - line with the new European standards for clinical research DIN EN ISO 14155-1 and DIN EN ISO 14155-2. Our special interest would be a cross-over trial comparing the efficacy, tolerability and compliance of both our two-part appliances in the treatment of snoring and mild to moderate OSAS with BMI < 28.
If you are interested to cooperate with us regarding both our new two-part mandibular advancement appliances please contact us.

TAP Appliance

Pancer J, Al-Faifi S, Al-Faifi M, Hoffstein V., Evaluation of variable mandibular advancement appliance for treatment of snoring and sleep apnea, Chest, 1999, 116:1511-1518

OBJECTIVE: To evaluate an adjustable mandibular positioning appliance for treatment of snoring and sleep apnea.

METHODS: One hundred thirty-four patients with baseline apnea/hypopnea index (AHI) of 37 +/- 28 events/h (mean +/- SD) received the appliance. The efficacy of the appliance was assessed by the following investigations, performed at baseline and with the appliance: polysomnography, Epworth sleepiness scale, bedpartners' assessment of snoring severity, patients' assessment of side effects, and overall satisfaction.

RESULTS: Thirteen patients were lost to follow-up. An additional 46 patients had no follow-up polysomnography, but answered the questionnaires. A total of 75 patients had polysomnography at baseline and with the appliance. We found a significant reduction in AHI from 44 +/- 28 events/h to 12 +/- 15 events/h (p < 0.0005) and a reduction in the arousal index from 37 +/- 27 events/h to 16 +/- 13 events/h (p < 0.05). Epworth scores fell from 11 +/- 5 to 7 +/- 3 (p < 0.0005). Bedpartners' assessment revealed marked improvement in snoring. For example, at baseline 96% of patients were judged to snore loudly "often" or "always" by their bedpartners, whereas only 2% were judged so while using dental appliance. The most frequent side effect was teeth discomfort, present "sometimes" or "often" in up to 32% of patients. Follow-up clinical assessment in 121 patients conducted on the average 350 days after the insertion of the appliance revealed that 86% of patients continued to use the appliance nightly; 60% were very satisfied with the appliance, 27% were moderately satisfied, 11% were moderately dissatisfied, and 2% were very dissatisfied.

CONCLUSION: We conclude that the adjustable mandibular positioning appliance is an effective treatment alternative for some patients with snoring and sleep apnea.

Silencer Professional

Ferguson KA, Ono T, Lowe AA, al-Majed S, Love LL, Fleetham JA, A short-term controlled trial of an adjustable oral appliance for the treatment of mild to moderate obstructive sleep apnoea, Thorax, 1997, 52: 362-368.

BACKGROUND: Although oral appliances are effective in some patients with obstructive sleep apnoea (OSA), they are not universally effective. A novel anterior mandibular positioner (AMP) has been developed with an adjustable hinge that allows progressive advancement of the mandible. The objective of this prospective crossover study was to compare efficacy, side effects, patient compliance, and preference between AMP and nasal continuous positive airway pressure (nCPAP) in patients with symptomatic mild to moderate OSA.

METHODS: Twenty four patients of mean (SD) age 44.0 (10.6) years were recruited with a mean (SD) body mass index of 32.0 (8.2) kg/m2, Epworth sleepiness score 10.7 (3.4), and apnoea/hypopnoea index 26.8 (11.9)/hour. There was a two week wash-in and a two week wash-out period and two treatment periods (AMP and nCPAP) each of four months. Efficacy, side effects, compliance, and preference were evaluated by a questionnaire and home sleep monitoring.

RESULTS: One patient dropped out early in the study and three refused to cross over so treatment results are presented on the remaining 20 patients. The apnoea/hypopnoea index (AHI) was lower with nasal CPAP 4.2 (2.2)/hour than with the AMP 13.6 (14.5)/hour (p < 0.01). Eleven of the 20 patients (55%) who used the AMP were treatment successes (reduction of AHI to < 10/hour and relief of symptoms), one (5%) was a compliance failure (unable or unwilling to use the treatment), and eight (40%) were treatment failures (failure to reduce AHI to < 10/hour and/or failure to relieve symptoms). Fourteen of the 20 patients (70%) who used nCPAP were treatment successes, six (30%) were compliance failures, and there were no treatment failures. There was greater patient satisfaction with the AMP (p < 0.01) than with nCPAP but no difference in reported side effects or compliance.

CONCLUSIONS: AMP is an effective treatment in some patients with mild to moderate OSA and is associated with greater patient satisfaction than nCPAP.

MDSA Appliance

Barnes M, McEvoy RD, Banks S, Tarquinio N, Murray CG, Vowles N, Pierce RJ, Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea, Am J Respir Crit Care Med, 2004, 170: 656-664

The efficacy of currently recommended treatments is uncertain in patients with mild to moderate obstructive sleep apnea (apnea-hypopnea index [AHI], 5-30). A group of 114 sleep clinic patients with an AHI of 5-30 have participated in a randomized controlled crossover trial of 3 months of treatment with each of nasal continuous positive airway pressure (CPAP), a mandibular advancement splint, and a placebo tablet. Outcomes were sleep fragmentation and hypoxemia, daytime sleepiness, quality of life, neurobehavioral function, and blood pressure. Both active treatments improved sleep outcomes, but positive airway pressure had a greater effect. The quality of life, symptoms, and subjective but not objective sleepiness improved to a similar degree with both treatments; however, many of the improvements seen in neuropsychologic function and mood were not better than the placebo effect. Some aspects of nocturnal blood pressure were improved with the splint but not with CPAP. This study has shown that although both CPAP and mandibular advancement splint effectively treated sleep-disordered breathing and sleepiness, the expected response in neurobehavioral function was incomplete. This may be due to the splint having a lesser therapeutic effect and CPAP being poorly tolerated and therefore used less in this patient group.