Treatment efficacy of a titratable oral appliance in obstructive sleep apnea patients: a prospective clinical trial.

PURPOSE: This prospective clinical trial assessed the therapeutic outcomes of patients with obstructive sleep apnea (OSA) treated with a novel duobloc custom-made titratable mandibular advancement device (OAm). MATERIAL AND METHODS: The modular Somnomed G2® OAm (Somnomed Europe AG, Zurich, Switzerland) with 'click-to-fit' adjustability provides instant feedback on the mandibular advancement. 161 consecutive patients with established diagnoses of OSA. Dental impressions were made and a bite registration in 75% of the maximal protrusion being the starting protrusion. Treatment response was defined as ≥ 50% decrease in apnea-hypopnea index (AHI). Treatment success was defined as 1a) AHI with OAm < 5 events/h sleep or 1b) AHI with OAm < 10 events/h. Treatment success and response were combined to define additional criteria: 2a) reduction in AHI ≥ 50% and AHI < 5 events/h; and 2b) reduction in AHI ≥ 50% and AHI <10 events/h. RESULTS: In 112 patients AHI decreased significantly from 25 ± 18/h sleep at baseline to 12 ± 13/h with the OAm (p < 0.001). The visual analogue scoring for snoring (VAS) decreased significantly from 7 ± 3 to 2 ± 2 (p < 0.001). Treatment response was achieved in 65 of 112 patients (58%); 31% and 57% of patients were treated successfully according to criteria 1a and 1b, respectively. Furthermore, 31% and 50% of patients were treated successfully according to criteria 2a and 2b, respectively. CONCLUSIONS: This clinical trial indicates that treatment with a novel custom-made OAm can reduce the severity of sleep-disordered breathing by significantly decreasing the AHI and VAS scores.

Treatment of obstructive sleep apnea using a custom-made titratable duobloc oral appliance: a prospective clinical study.

PURPOSE: This prospective clinical study investigates the efficacy of a specific custom-made titratable mandibular advancement device (MAD) for the treatment of obstructive sleep apnea (OSA). This MAD has attachments in the frontal teeth area that allow for progressive titration of the mandible. METHODS: Sixty-one adult OSA patients were included (age, 46.7 ± 9.0 years; male/female ratio, 45/16; apnea-hypopnea index (AHI), 23.2 ± 15.4 events/h sleep; body mass index, 27.9 ± 4.1 kg/m²). After an adaptation period, titration started based on a protocol of symptomatic benefit or upon reaching the physiological limits of protrusion. As a primary outcome, treatment response was defined as an objective reduction in AHI following MAD treatment of ≥50 % compared to baseline, and treatment success as a reduction in AHI with MAD to less than 5 and 10 events/h sleep. Compliance failure was defined as an inability to continue treatment. RESULTS: A statistically significant decrease was observed in AHI, from 23.4 ± 15.7 at baseline to 8.9 ± 8.6 events/h with MAD (p < 0.01). Treatment response was achieved in 42 out of 61 patients (68.8 %), whereas 42.6 % met criteria of AHI < 5 and 63.9 % achieved an AHI < 10 events/h sleep, respectively. Four patients (6.6 %) were considered as "compliance failures." CONCLUSIONS: The present study has evaluated the efficacy of a specific custom-made titratable MAD in terms of sleep apnea reduction.

Intracranial complications of acute otitis media and Gradenigo's syndrome.

We describe the case of a 12-year-old girl with acute otitis media complicated by acute mastoiditis, epidural empyema, thrombosis of the sigmoid sinus and paralysis of the abducens nerve. The patient underwent a mastoidectomy on the left side combined with drainage of the epidural empyema through an extended burr holl and received intravenous antibiotics for 6 weeks and anticoagulation for 12 weeks. This report discusses the intracranial complications of acute otitis media, which were a common problem before the advent of adequate antibiotic drugs but have become rare since their introduction.

Non-CPAP therapies in obstructive sleep apnoea.

In view of the high prevalence and the relevant impairment of patients with obstructive sleep apnoea syndrome (OSAS) lots of methods are offered which promise definitive cures for or relevant improvement of OSAS. This report summarises the efficacy of alternative treatment options in OSAS. An interdisciplinary European Respiratory Society task force evaluated the scientific literature according to the standards of evidence-based medicine. Evidence supports the use of mandibular advancement devices in mild to moderate OSAS. Maxillomandibular osteotomy seems to be as efficient as continuous positive airway pressure (CPAP) in patients who refuse conservative treatment. Distraction osteogenesis is usefully applied in congenital micrognathia or midface hypoplasia. There is a trend towards improvment after weight reduction. Positional therapy is clearly inferior to CPAP and long-term compliance is poor. Drugs, nasal dilators and apnoea triggered muscle stimulation cannot be recommended as effective treatments of OSAS at the moment. Nasal surgery, radiofrequency tonsil reduction, tongue base surgery, uvulopalatal flap, laser midline glossectomy, tongue suspension and genioglossus advancement cannot be recommended as single interventions. Uvulopalatopharyngoplasty, pillar implants and hyoid suspension should only be considered in selected patients and potential benefits should be weighed against the risk of long-term side-effects. Multilevel surgery is only a salvage procedure for OSA patients.

A novel tongue implant for tongue advancement for obstructive sleep apnea: feasibility, safety and histology in a canine model.

Obstructive sleep apnea (OSA) is a sleep related breathing disorder caused by partial or complete collapse of the upper airway during sleep. The disease is linked with important cardiovascular and cerebrovascular morbidity and mortality. Tongue base collapse is a major cause of upper airway occlusion in OSA and present surgical procedures to prevent this are invasive and inefficient. A novel implantable system to stabilize the tongue was evaluated in a canine model for feasibility, safety and histology. Successful implantation of the Advance System was performed in 21 canines and follow-up evaluations were performed at 30, 60, 90, 120 and 150 days. No technical or clinical adverse events were seen during the procedure. Minor clinical adverse events at some of the follow-up evaluations were treated successfully. Histologic evaluation of the implant was performed at different time points during follow-up and showed good biocompatibility, stability and osteointegration. The outcome of this study resulted in an implant for adjustable tongue advancement in humans with OSA.

Outcome of sleep endoscopy in obstructive sleep apnoea: the Antwerp experience.

OBJECTIVES: Snoring and obstructive sleep apnoea (OSA) result from upper airway (UA) collapse during sleep. Sleep endoscopy is a dynamic evaluation of the UA that can be used to determine the site(s) of collapse during respiratory events. This study evaluates the feasibility and outcome of sleep endoscopy in patients with OSA, compares the findings with the literature, and reviews the therapeutic advice given to patients. METHODOLOGY: A retrospective analysis was conducted of the data for 70 OSA patients in whom UA surgery was considered. Sleep endoscopy was performed after IV administration of midazolam and propofol. The UA was visualised and assessed for the location of UA flutter, narrowing or collapse. Feasibility and safety were evaluated retrospectively. Outcome data were described as type and pattern of flutter and/or collapse. Treatment advice given to the patients was reviewed. RESULTS: Sleep endoscopy showed monolevel palatal collapse in 31.9%, monolevel tongue/hypopharyngeal collapse in 27.8% and multilevel collapse in 31.9% of patients. In 5.6% of patients, no collapse was found. In all patients except 2, reliable assessment proved possible of the site(s) of obstruction. No side effects were reported. CONCLUSION: Sleep endoscopy is feasible and safe in daily practice when sedation is performed by an anaesthesiologist and can be used to locate the site of collapse in the UA. Sleep endoscopy findings in our study sample, as well as in the literature, differ according to the content of the study sample and the method of sedation. Treatment advice may differ from sleep endoscopy findings since other factors such as age and patient preferences need to be considered.

Allograft tympanoplasty type 1 in the childhood population.

Seventy allograft type 1 tympanoplasties in children under 16 years of age were studied retrospectively. Only patients with a tympanic membrane perforation without cholesteatoma and a normal ossicular chain were included. Short-term and long-term anatomic and functional results were analyzed after a mean follow-up of 40 months. The overall short-term take rate was 97% and the long-term take rate was 88%. A number of variables with alleged prognostic value for surgical outcome were analyzed, but none showed statistical correlation with either anatomic or functional results. A median hearing gain of 10 dB was achieved, which was stable over time. We conclude that allograft tympanoplasty type 1 in this group of children is anatomically and functionally successful regardless of age.

Benign fibrous histiocytoma of the larynx: presentation of a case and review of the literature.

A case of a benign histiocytoma of the larynx in a 39-year-old man is presented. Laryngeal fibrous histiocytoma is extremely rare. Its pathology is described including arguments for benignity. The literature is reviewed and management is discussed.

Cardiovascular mechanisms and consequences of obstructive sleep apnoea.

Obstructive sleep apnoea (OSA) is considered as a risk factor for the development of arterial hypertension, coronary artery disease (CAD), myocardial infarction and stroke. These clinical manifestations are the consequences of elevated sympathetic activity, cardiovascular variability, intrathoracic pressure changes, inflammation, oxidative stress, endothelial dysfunction, insulin resistance and thrombosis provoked by OSA. As a result, OSA is often present in patients with cardiovascular disease (CVD) and the increased prevalence of CVD in OSA population raises both cardiovascular morbidity and mortality and the demand of healthcare resources. Observational cohort studies indicate that untreated patients with OSA have an increased risk of fatal and non-fatal cardiovascular events, an increased risk of sudden cardiac death during the sleeping hours and a higher risk of stroke or death from any cause. Continuous positive airway pressure (CPAP) and oral appliance therapy are the two treatments for OSA whose effects on cardiovascular endpoints have been assessed in randomised trials. There is increasing evidence that adequate CPAP therapy leads to a significant reduction in cardiovascular morbidity.

External nasal dilation reduces snoring in chronic rhinitis patients: a randomized controlled trial.

Chronic rhinitis patients often suffer from unrefreshing sleep and snoring, related to increased nasal resistance to airflow. Previous trials based on subjective assessment of snoring have demonstrated beneficial effects of Breathe Right (BR), a noninvasive external nasal dilator. Polysomnography (PSG) was applied to objectively assess the effects of BR on snoring. Twelve nonobese chronic rhinitis patients participated in the present study, which had a randomized, placebo-controlled design. The presence of snoring and the absence of sleep apnoea was demonstrated during a baseline overnight sleep study. Patients were then randomized for placebo or true nasal dilator treatment, which was also assessed by overnight PSG. The use of BR had no effect on sleep quality, arousal-index apnoea-hypopnoea-index or snoring loudness. Snoring frequency was significantly lowered by BR (173+/-29 snores x h(-l)), compared with placebo (258+/-34 snores x h(-1); p=0.016). The results support the hypothesis that Breathe Right is effective in reducing the amount of snoring in patients with chronic rhinitis. This objective finding is in line with some other reports on subjective improvement of snoring, based upon the judgement of bedpartners.

Sleep related breathing disorders: the respiratory control system and its instability during sleep.

Respiratory control and instability in the breathing pattern during sleep. Unstable breathing during sleep plays an important role in the development of sleep related breathing disorders (SRBD). Periodic breathing, as a hallmark of this instability, is a common initiator of these disorders. In addition, structure and function of the upper airway are prone to intrinsic and extrinsic, congenital and acquired abnormalities which are as well responsible for the pathogenesis of SRBD.

Morphometric analysis of the uvula in patients with sleep-related breathing disorders.

The upper-airway mucosa in obstructive sleep apnea (OSA) patients and snorers is often described as edematous and hyperplastic. The morphologic aspects of the pharyngeal mucosa, and in particular the mucosa of the uvula and soft palate, in OSA patients are, however, not well described. The aim of the present retrospective study therefore was to perform histologic examination of the pharyngeal mucosa obtained from patients with various forms of sleep-related breathing disorders, including primary snoring. A midsagittal section of uvulas obtained by uvulopalatopharyngoplasty (UPPP) was investigated in 34 OSA patients and 9 non-apneic snorers. Control tissues were taken by autopsy in 19 patients not known to have OSA or snoring. A morphometric point counting technique was used to determine the tissue composition. The data showed that OSA patients and non-apneic snorers had a significantly greater percentage of intercellular space than controls (65.7% vs 54.0%; P = 0.006). Control uvulas contained more muscle than OSA and snorers (14.0% vs 7.8%; P = 0.006). Moreover, the covering epithelium was significantly thicker in OSA and snorers than in controls (variance ratio = 7.64; P = 0.008). When taking body mass index (BMI) into account, no correlation was found between fat deposition and BMI. Findings showed that an increased clinical severity of OSA did not affect the tissue composition. Indeed, uvula morphology was similar in OSA patients with respect to non-apneic snorers. Since the increased amount of intercellular space is the expression of edema, we hypothesize that these mucosal changes together with hyperplasia of the covering epithelium are secondary effects to snoring. They presumably play a minor role in the etiopathogenesis of OSA, but may increase the severity of OSA by further narrowing the pharyngeal lumen.

Diagnostic procedures in head and neck cancer.

Accurate, methodical diagnostic work up and staging are of the most importance in the treatment of Head and Neck tumours. It allows an initial multidisciplinary decision making, giving the patient the best chance of curation, with the least morbidity. In this paper the authors try to give a generally accepted work-up and try to get in to some of the newer techniques.