Media / Studies

Snoring Issues (PDF)
Mudgee Guardian 19th June 2008

Stop Snoring - This actually works!
Mudgee Guardian 5th September 2008


 

The Velumount method is scientifically tested: The first published results show impressive results.

The Velumount method has been submitted for further scientific testing and includes snorers with or without obstructive sleep apnoea. Likewise, Velumount P/L leads internal quality controls and studies with snorers and sleep apnoea sufferers using the Velumount device.

Velumount studies published: The first detailed medical study, showing the effectiveness of the Velumount® method performed in the Cantons Hospital Liestal in Basel, Switzerland under the direction of Professor Dr. Med. Kurt Tschopp, was introduced on 5th June 2008 at the Spring Congress of the Swiss Ear Nose and Throat Specialists in Zug, Switzerland. Read the noteworthy results in the following Abstract.


 

Velumount studies

•  Influence of Nasal Resistance
•  Oral appliances
•  Oral appliance therapy
•  Oral appliance treatment
•  Maxillary Expansion
•  Therapy of snoring and Obstructive Sleep Apnoea using the Velumount Palatal Device

 

Influence of Nasal Resistance
on oral appliance treatment outcome in obstructive sleep apnoea

Biao Zeng, MD, PhD, Andrew T. Ng, MBBS, Jin Qian, MBiomedEng, Peter Petocz, PhD, M. Ali Darendaliler, PhD, Peter A Cistulli, MBBS, PhD

SLEEP 2008; 31 (4): 543 - 547.
Centre for Sleep Health & Research, Department of Respiratory Medicine, Royal North Shore Hospital, University of Sydney, Australia.


It has been recognised that nasal airway resistance (NAR) is elevated in patients with OSA. However, little is known regarding the influence of nasal resistance on mandibular advancement splint (MAS) treatment outcomes in OSA patients. We hypothesized that nasal resistance differs between MAS responders and non responders and therefore may influence treatment outcomes. Thirty-eight patients with known OSA underwent polysomnography while wearing a custom-made MAS. Treatment outcome was defined as follows: Responders (R) > or =50% reduction in AHI, and Non responders (NR) as

This study suggests the need for an interdisciplinary approach between ENT Surgeons and Sleep Physicians in treating OSA – a condition demonstrating a multifactorial pathophysiology. <menu>

 

Oral appliances
in the management of sleep disordered breathing: The Physician's Perspective

A Chan , R Lee, K Sutherland, P Cistulli
Centre for Sleep Health and Research, Department of Respiratory Medicine, Royal North Shore Hospital, St Leonards, NSW, Australia, Woolcock Institute of Medical Research, University of Sydney, NSW, Australia

Oral Appliances are an alternative to continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnoea (OSA). They are worn during sleep and aim to maintain the patency of the upper airway by increasing its dimensions and reducing its collapsibility. Although CPAP is a highly efficacious treatment, its obtrusive nature limits clinical effectiveness. Oral appliances are a simpler form of treatment and are often considered by patients to be more acceptable compared to CPAP. Treatment of OSA, with an oral appliance requires a multidisciplinary approach. The clinical practice parameters of the American Academy of Sleep Medicine recommend their use for mild to moderate OSA; or for patients with severe OSA who are unable to tolerate or refuse treatment with CPAP. Oral appliances have been shown to have a beneficial impact on a number of important clinical end-points including the polysomnographic indices of OSA, subjective and objective measures of sleepiness, blood pressure, aspects or neuropsychological functioning and quality of life. Elucidation of the mechanism of action of oral appliances has provided insight into the factors which predict treatment response and may improve the selection of patients for this treatment modality. Although not as efficacious as CPAP for improving the polysomnographic indices of OSA, oral appliances are often considered by patients to be a more acceptable treatment. This has the potential to translate to better treatment compliance and may provide a similar level of effectiveness in clinical practice. <menu>

 

Oral appliance therapy
in Obstructive Sleep Apnoea-Hypopnea Syndrome - A clinical study on therapeutic outcomes

A Hoekema PhD thesis, University Medical Centre Groningen Department of Oral and Maxillofacial Surgery. pp 110 (2007)

Background:
Oral-appliance therapy is emerging as an alternative to continuous positive airway pressure (CPAP) as therapy for the obstructive sleep apnea-hypopnea syndrome (OSAHS). In clinical practice, however, oral appliances are used primarily for patients who do not respond to CPAP therapy. We hypothesized that an oral appliance is not inferior to CPAP in treating OSAHS effectively.

Method:
We randomly assigned 103 OSAHS patients to oral-appliance or CPAP therapy. After eight weeks, treatment effect was assessed with polysomonography. Follow-up review was extended for patients requiring adjustments to therapy and ended with a patient’s final polysomnographic evaluation or when a patient discontinued treatment. We then determined the proportion of patients for whom oral-appliance or CPAP therapy was effective. For the difference in effectiveness (oral-appliance minus CPAP therapy), a 95% two-sided confidence interval was calculated. Non-inferiority of oral-appliance therapy was considered established when the lower boundary of this interval exceeded - 25%.

Results:
Treatment was effective for 39 of 51 patients using the oral appliance (76.5%) and for 43 of 52 patients using CPAP (82.7%). The lower boundary conclusion: In this randomised parallel trial, oral-appliance therapy was not inferior to CPAP as effective treatment of OSAHS. Subgroup analysis suggested that an oral appliance is particularly indicated for patients with non-severe disease. <menu>

 

Oral appliance treatment
for obstructive sleep apnoea

Chan AS, Lee RW, Cistulli PA
CHEST. 2007 Aug; 132(2): 693-9.
Centre for Sleep Health and Research, Royal North Shore Hospital, St Leonards NSW 2065, Australia.


Oral appliances for the treatment of obstructive sleep apnea (OSA) are worn during sleep to maintain the patency of the upper airway by increasing its dimensions and reducing its collapsibility. Oral appliances are a simpler alternative to continuous positive airway pressure (CPAP). Over the last decade, there has been a significant expansion of the evidence base to support the use of oral appliances, with robust studies demonstrating their efficacy. This work has been underpinned by the recognition of the importance of upper airway anatomy in the pathophysiology of OSA. The updated practice parameters of the American Academy of Sleep Medicine now recommend their use for mild-to-moderate OSA, or for patients with severe OSA who are unable to tolerate CPAP or refuse treatment with CPAP. Oral appliances have been shown to have a beneficial impact on a number of important clinical end points, including the polysomnographic indexes of OSA, subjective and objective measures of sleepiness, BP, aspects of neuropsychological functioning, and quality of life. Elucidation of the mechanism of action of oral appliances has provided insight into the factors that predict treatment response and may improve the selection of patients for this treatment modality. Longitudinal studies to characterize the long-term adverse effects of oral appliance use are now beginning to emerge. Although less efficacious than CPAP for improving the polysomnographic indexes of OSA, oral appliances are generally preferred by patients. This has the potential to translate to better patient adherence and may provide an equivalent health outcome. <menu>

 

Maxillary Expansion
Treatment of obstructive sleep apnea syndrome by rapid maxillary expansion

Cistulli PA, Palmisano RG, Poole MD.
SLEEP. 1998 Dec 15;21(8):831-5
Centre for Sleep Disorders & Respiratory Failure, St George Hospital, NSW, Australia.


The precise role of maxillary constriction in the pathophysiology of obstructive sleep apnea (OSA) is unclear. However, it is known that subjects with maxillary constriction have increased nasal resistance and resultant mouth-breathing, features typically seen in OSA patients. Maxillary constriction is also associated with alterations in tongue posture which could result in retroglossal airway narrowing, another feature of OSA. Rapid maxillary expansion (RME) is an orthodontic treatment for maxillary constriction which increases the width of the maxilla and reduces nasal resistance. The aim of this pilot study was to investigate the effect of rapid maxillary expansion in OSA. We studied 10 young adults (8 male, 2 female, mean age 27 +/- 2 [sem] years) with mild to moderate OSA (apnea/hypopnea index-AHI 19 +/- 4 and minimum SaO2 89 +/- 1%), and evidence of maxillary constriction on orthodontic evaluation. All patients underwent treatment with RME, six cases requiring elective surgical assistance. Polysomnography was repeated at the completion of treatment. 9 of the 10 patients reported improvements in snoring and hypersomnolence. There was a significant reduction in AHI (19 +/- 4 vs 7 +/- 4, p < 0.05) in the entire group. In seven patients, the AHI returned to normal (i.e., = < 5); only one patient showed no improvement. These preliminary data suggest that RME may be a useful treatment alternative for selected patients with OSA. <menu>

 

Therapy for Snoring and Obstructive Sleep Apnea using the Velumount Palatal Device
Position of the Velumount palatal device (Gaumenspange) for Rhonchopathy and Obstructive Sleep Apnoea (OSA)

Prof. Dr. med. Kurt Peter Tschop (Chefarzt HNO-Klinik, Kantons Spital Liestal in Basel CH, email kurt.tschop@ksli.ch ), Fabian Schauer, Esther Genoveva Thomaser
Clinic for Neck, Nose, Ear disorders, Neck and Facial surgery, Canton Hospital Liestal (Basel Switzerland)


Summary
Introduction:
The Velumount Method was developed and patented by A. Wyss from Bern (Switzerland) for the treatment of snoring and obstructive sleep apnoea (OSA). The principle consists of an external stinting of the retro palatal area and an ante flexion of the velum palatinum. The target of the presented work is the scientific evaluation of the success of the Velumount Method.
Method: During May 2007 - May 2008, 37 patients were evaluated with and without the Velumount. With a nocturnal polysomnography of the upper airways combined with a respiratory polygraphy the Apnoea-Hypopnoea-Index (AHI), the average Oesophagus pressure (Pes) and the percentage distribution of obstructions in the retro-palatal and retro-lingual were defined. With the aid of a questionnaire, the snoring index (1-10) as well as day tiredness with the Epworth Sleepiness Scale (ESS) was established.

Results: With Velumount a reduction was achieved for the snoring index from average 8.3 (SD+/_3.4) to 3.7 (SD+/-2.5), the point scale in ESS from average 8.2 (SD+/-4.3) to 3.9 (SD+/-3.4) and the Pes from average 15 cmH2O (SD+/-6.8) to 11.4 cmH2O (SD+/-6.6). The AHI by n=22 OSA patients without Velumount was as an average of 23.6 (SD+/-10.6) and reduced with the Velumount to an average of 14.0 (SD+/-12.9). All changes were highly significant (Wilcoxon test: p
Conclusion: The Velumount Method is effective for snoring and OSA and the nocturnal Polysomnography of the upper airways validates the expectation of a therapy success. <menu>