Snoring
IssuesMudgee Guardian 19th June 2008
Swiss
Article
Der Bund 8th July 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.
On 18th April 2008 in Fribourg Switzerland, Dr. Med. Strobel, specialist in
Pneumology in Basel, introduced an investigation,
the purpose of which was to prove the ineffectiveness of the Velumount method.
This however failed. Read the
conclusions of the study with comments from Velumount.
• 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 <50% reduction in AHI. NAR was measured using posterior
rhinomanometry in both sitting and supine positions, with and without MAS. The
mean AHI in 26 responders was significantly reduced from 29.0 +/- 2.9/h to 6.7
+/- 1.2/h; P < 0.01). In 12 non responders there was no significant change
in AHI (23.9 +/- 3.0/h vs 22.0 +/- 4.3/h; P=ns). Baseline NAR was significantly
lower in responders in the sitting position compared to non responders (6.5
+/- 0.5 vs 9.4 +/- 1.0 cm H2O; P < 0.01). There was no significant change
in NAR (from baseline) with MAS in either response group while in the sitting
position, but in the supine position NAR increased significantly with MAS in
the non responder group (11.8 +/- 1.5 vs. 13.8 +/- 1.6 cm H2O/L/s; P < 0.01).
Logistic regression analysis revealed that NAR and BMI were the most important
predictive factors for MAS treatment outcome. These data suggest that higher
levels of NAR may negatively impact on treatment outcome with MAS.
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<0.001).
With a snoring index of <3 socially classified as not disturbing, the response
rate was 65%. Regarding the AHI and using the Sher criteria (AHI <20/h and
reduction compared to starting value around 50%) the result is a 55% response
rate. A normalisation of a raised Pes (Pes <10 cmH2O) resulted in 41%. The
retro-palate obstructive AHI Value had a predictive value with regard to overall
improvement of AHI (Spearman r=0.46; p=0.004).
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>
Velumount® - For the Prevention of Snoring and Obstructive Sleep Apnoea (OSA)
