Kliniske test

Mange undersøgelser har påvist, at anti-snorkeskinner kan være en effektiv langsigtet løsning mod snorkeproblemer og mild til moderat søvnapnø.

Nedenfor kan du orientere dig i de kliniske studier af SnorBan og SomnoFit.

Der er foretaget videnskabelige undersøgelser af SnorBan i Tyskland og USA. Forskningsresultaterne er offentliggjort i anerkendte tidsskrifter.

Et Studie foretaget ved Mannheim Sleep Medicine Center viser, at SnorBan effektivt fjerner eller reducerer snorken for mere end 7 ud af 10 personer (76,9%). For alle studiets søvnapnøe patienter blev de natlige respirationspauser nedsat (gennemsnitlig AHI reduktion på 51%). 

Du kan orientere dig i studiernes resultater herunder: 

Summary:

1. Trial objectives
In an open study design the following objectives in patients suffering from snoring with and without sleep-related respiration disturbances were to be investigated under application of the oral mandibular device SnorBan:

- the influence on the duration and intensity of snoring,
- the frequency of apnea and hypopnea during sleep,
- the oxygen content in the blood to examine the sleep structure and finally the
- daytime sleepiness/fatigue.

The oral mandibular advancement device consists of a thermoflexible material that is fitted to the patient after heating up in hot water and used during the night.

2. Inclusion criteria
- nocturnal snoring
- proper nose respiration
- complete tooth status

3. Exclusion criteria
- gulping (würgen) when pressing with the spatula on the rear two thirds of the tongue
- gulping when brushing teeth
- progenia
- extreme dysgnathia that makes fitting impossible

4. Methods
After complete polysomnography medical personnel performed the fitting of the mouthpiece in those patients, who met the inclusion criteria and had given informed consent to participate in the clinical study. After fitting the correct tightness and the form of the prosthesis were controlled. After a period of 4 to 8 weeks patients got accustomed to the mouthpiece and subsequently underwent follow-up polysomnography, clinical examination and were interviewed about symptoms, treatment effectiveness, side effects and satisfaction with their mouthpiece.

5. Study population
Out of 53 patients who were consecutively selected 5 rejected study enrollment, and 7 patients were excluded for dental reasons. Altogether 41 patients were supplied with SnorBan, whereby 39 appeared for re-examination and thus made up the evaluable group that consisted of 33 men and 6 women with an average age of 51.1 + / - 9.2 years.

6. Results
All patients confirmed to get well along with the oral mandibular advancement device. A total of 79.5% confirmed that they were very satisfied (23.1%) or satisfied regarding comfort of everyday usage and effectiveness, only 20.5% were dissatisfied. Under SnorBan 45.9% of all patients reported an improved general health condition, only 7.7% reported a general impairment.

Increased salivation was indicated by 22 patients. Transient toothache in the morning was indicated by 17 patients, jaw joint pain by 7 patients, and nausea by 3. Deformations by using the mandibular advancement device had not been indicated. The average period of time of getting accustomed to the mouthpiece was in between a time frame of 0 to 21 days (average value: 4 days).

Furthermore, 43.6% of patients indicated a significant and still 33.3% a moderate reduction of the intensity of snoring and its duration under SnorBan. Regarding sleep apnea patients it was indicated that the nocturnal respiratory arrests had decreased considerably in all cases (average AHI reduction of around 51%).

Polysomnography revealed an average reduction of the total snoring period by 59.5% on average. Regarding patients with an initial AHI exceeding 10/h this value decreased under SnorBan by 50 to 80% on average. Even a reduction of initially high AHI values to those being below 10/h had been demonstrated, e.g. from initially 56.5 to 3.8. In one case there was an increase of the AHI value from initially 6.5/h to 25.6/h. Overall compliance was 75%.

7. Judgement
Neither severe side effects nor health endangering complications had been reported under SnorBan.

Currently available subjective and objective outcome parameters are interpreted as promising hints for the application of SnorBan not only in habitual snoring, but in obstructive sleep apnea too.

The use of SnorBan is medically recommended in appropriate indications. In- and exclusion criteria must be considered

1. Background:
In the treatment of obstructive sleep apnea (OSA), mandibular advancing devices (MAD) are usually individually fabricated on plaster casts of both jaws from polymethyl-methacrylate. The potential disadvantages of these devices are (1) the costs and (2) the time required to construct the device.

2. Objective:
In this study, the efficacy and feasibility of a cheap MAD consisting of thermoplastic material (SnorBanTM), which can be directly moulded intraorally, were evaluated.

3. Methods:
In a prospective study, the effect of a MAD consisting of thermoplastic material was investigated in 22 consecutive patients with OSA ((respiratory disturbance index (RDI) 32.6 ± 18.4/h)). Polysomnographic sleep was recorded prior to treatment and after 3 months of treatment with the MAD.

4. Results:
Three of the 22 patients who did not tolerate the MAD were excluded from the analysis, whereas 11 patients were classified as responders. In the responder group, the mean RDI decreased from 27.6 ± 7.3 to 7.3 ± 2.9 (p < 0.01), correspondingly the sleep quality and the Epworth Sleepiness Scale improved (p < 0.05). Eight patients proved to be non-responders without relevant changes for the measured parameters.

5. Conclusions:
In 50% (11 of 22) of the patients, the MAD improved the OSA to a clinically relevant degree. In contrast to the majority of established MAD, the MAD investigated is cheap and immediately adaptable and thus a feasible feasible strategy to “screen” the efficacy of this therapeutic principle. Thus the construction of unnecessary MAD is avoided.

1. Objectives
Oral appliances are designed to treat snoring and sleep apnea by advancing the mandible and tongue. We test the hypothesis that an oral appliance affects palatal snoring as well as tongue base obstruction.

2. Methods
Prospective observational cohort study. Sixty patients with a chief complaint of snoring with or without apnea were enrolled. Each patient underwent a home sleep test followed by 3 weeks sleeping with an oral appliance. Each patient then underwent a repeat home sleep test while using the device.

3. Results
There was a statistically significant improvement in the snores per hour (P = 0.0005), the maximum snoring loudness (P = 0.0001), average snoring loudness (P = 0.00001), and the percentage of palatal snoring (P = 0.0007). There was also a significant decrease in oxygen desaturation events (P = 0.003).

4. Conclusions
This study suggests oral appliances may be effective treatment for both palatal and tongue base snoring.

Læs gerne mere om SnorBan på Medline - Online adgang til medline
Brug søgeordet: "SnorBan"

SomnoFit virker efter nøjagtig samme princip som snorBan, men er endnu ikke dokumenteret i egne studier. Trods variation i udformningen af anti-snorkeskinner er den kliniske effekt bemærkelsesværdig konsistent (se review).

Der findes tandlæge fremstillede anti-snorkeskinner, hvis design er sammenlignelig med SomnoFit, såsom "Silensor", markedsført i USA under varemærket "Silent Nite" og "EMA" (Elastic Mandibular Advancement). Vi konkluderer derfor, at en tilsvarende klinisk effekt kan forventes for SomnoFit.

Med hensyn til de tandlægefremstillede anti-snorkeskinner "Silensor" og "EMA" henvises til nedenstående publikationer:

Resume:
Oral mandibular advancement devices are becoming an increasingly important treatment alternative for obstructive sleep apnea (OSA). The first aim of the study was to determine whether a new oral elastic mandibular advancement device (EMA) prevents pharyngeal airway closure during sleep in patients with OSA. The second aim of the study was to determine if the polysomnographic response to the oral mandibular advancement device was dependent on the site of airway closure. 

Overnight polysomnograms were performed in 28 untreated OSA subjects with and without EMA. A third polysomnogram was performed in 12 of the subjects to determine the site of airway closure without the device. Site of airway closure above or below the oropharynx was determined by measuring the respective presence or absence of respiratory fluctuations in oropharyngeal pressure during induced occlusions in non-rapid eye movement (NREM) sleep. 

Mean apnea-hypopnea index (AHI) was 52.6 +/- 28.2 (SD) events/h without the device and 21.2 +/- 19.3 events/h with the device. Nineteen subjects (68%) had at least a 50% reduction in AHI with the device. The change in AHI with the device (AHI without device - AHI with device) was directly related to the AHI without the device. All three subjects with airway closure in the lower pharyngeal airway had a greater than 80% reduction in AHI with the device. Two of the nine subjects with airway closure in the velopharynx had a similar therapeutic response. The results show the effectiveness of EMA in the treatment of OSA.

The results also indicate that polysomnographic severity of OSA and the site of airway closure should not be used to exclude patients from this oral device treatment.

Original publikation →

Resume:
This prospective, randomized, cross-over trial was designed to compare the efficacy of a mandibular advancement splint (MAS) with that of nasal continuous positive airway pressure (nCPAP) in patients with obstructive sleep apnoea (OSA). 

Twenty-four patients (20 males and four females) with mild to moderate OSA (AHI between 10 and 49 events per hour) were enrolled in the study. Each patient used both MAS and nCPAP, with the initial therapy being allocated at random. Treatment periods lasted for two months with a two-week wash-out interval between. 

Polysomnography was performed prior to the study and after each clinical intervention. Patient and partner questionnaires were used to assess changes in general health and daytime somnolence. 

The AHI decreased from 22.2 to 3.1 using nCPAP, and to 8.0 using the MAS (P < 0.001 for both devices) and there was no statistically significant difference between the two treatments. The Epworth Sleepiness Score (ESS) fell from 13.4 to 8.1 with nCPAP, and to 9.2 with MAS (P < 0.001), again with no differences between the use of MAS or nCPAP. The questionnaire data showed an improvement in general health scores (P < 0.001) after both treatments, but daytime sleepiness only improved significantly using nCPAP (P < 0.001). Despite this, 17 out of the 21 subjects who completed both arms of the study preferred the MAS. 

The splints were well tolerated and their efficacy suggests that the MAS may be a suitable alternative to nCPAP in the management of patients with mild or moderate OSA.

Original publikation →