Treatment of patients with Sleep disorders as Snoring and Obstructive

Apnea-Hypopnea by a palatum molle supporting tongue retaining device:

Study of efficacy and patient comfort

(To be submitted to ”Sleep and Breathing”)

 

Drs. Ronald J. van der Wal , Drs. Chimène A.V. Jongejans , Judith Stallings

Absence of financial support and conflicts of interest
Keywords: Sleep disorders, Sleep apnea, Snoring treatment, Oral appliance, Tongue retaining device, TRD, MRD, OSASH, TMJ, Palatum molle

 

 

Abstract

 

For a group of 54 patients treated for snoring or obstructive sleep apnea syndrome a study was conducted regarding the efficacy and patients comfort of an oral appliance after 3 years of prescription. The appliance investigated was an oral appliance, which prevents the tongue to move backwards narrowing the airway and furthermore supports the palatum molle.
Of this group of patients, 26 (48%) were classified to have an obstructive sleep apnea syndrome with AHI-values of over 15. Adherence rates after 3 years of 61% (AHI≥15) were found, while for the group with AHI<15 adherence rates of 72% were reported. These adherence rates are higher than reported in literature.
In contrast to other oral devices no side effects were reported, as disordered occlusion, mandibular reposition and temporomandibular joint problems. The group who did not adhere to the appliance, mainly reported discomfort (e.g. excessive salivation) and inefficacy as reason for termination of use. Surprisingly, for 75% of the patients reporting inefficacy repeated sleep registration tests revealed reduction of AHI-values of more than 50%.
It could be concluded that of the group of 54 patients 72% were treated effectively by the oral device of study. This success percentage is above average compared to literature data.
It is concluded that the design of the appliance and especially the depressor and its force on the tongue plays a very important role in efficacy and patient comfort as might be concluded by comparing the results of this study and of the earlier study of Schönhofer.

Introduction

 

Snoring has been recognized more and more as a serious problem last ten years, which may affect people’s health and social life heavily. The snorer himself might suffer from sleep disturbances, but most times their partners are affected more badly. Often these sleep disturbances might create relational problems. Of men aged 30 to 60 years the prevalence of snoring is around 50%. Estimates indicate that more than 140 millions US citizens snore.
Snoring can occur alone or be the presenting feature of obstructive sleep apnea.
Patients with sleep apnea (also known as OSAHS, Obstructive Sleep Apnea-Hypopnea Syndrome) have periods when breathing is stopped while sleeping 1. These interruptions can last 10 seconds or longer and are caused when the muscles in the soft palate, uvula, tongue and/or tonsils relax during sleep. Such breathing interruptions often result in oxygen desaturations. The same process is involved with normal snoring, however at sleep apnea the airway narrows seriously. Proper sleep may become impossible amongst others due to depletion of REM and non-REM stages 3 and 4, resulting in severe fatigue and a decreased quality of life. Many medical studies have revealed that sleep apnea in adults can increase the risk of serious health problems such as headaches, loss of alertness, daytime sleepiness, memory and judgment problems, irritability, difficulty concentrating, heart failure and strokes. In the study of Siverten et al 2 the large economic impact of sick leave and work disability of sleep apnea patients in Norway became evident. Recently Cross et al 3 even reported visual evidence of severe structural damage in regions of the brain in people with OSAHS, influencing characteristics as mood and memory. It has been statistically proven that snorers have a higher rate of car crashes and work-related accidents 4,5. According to the American Sleep Apnea Association, sleep apnea affects at least 20 millions US citizens of all ages. Although snoring and sleep apnea has been associated with heavy weight, bad condition and alcohol use, studies of young, professional football players calls even attention to sleep disorder caused by sleep apnea at millions of undiagnosed, younger men 6. Yet still because of the lack of awareness by the public and healthcare professionals, the vast majority remain undiagnosed and therefore untreated, despite the fact that this serious disorder can have significant consequences 7.
With the growing recognition of snoring and sleep apnea as a serious medical condition, more and more attention is given to the development of products and treatments to prevent snoring and sleep apnea. E.g. the U.S. Patent and Trademark office lists 2933 patents related to the treatment of snoring and apnea 8.
Examples of products available are mandibular repositioning devices (MRD ), tongue retaining devices (TRD ) and forced air pressure devices(CPAP ). Further, surgical and radiofrequency interventions, removing, repositioning or reinforcing obstructing tissue are increasingly popular to treat snoring and sleep apnea.
Medisch Centrum Molendael, Baarn, the Netherlands (nowadays: Meander Medisch Centrum) has been treating sleep disorders since 1995 and is one of the first hospitalised sleep test centres in the Netherlands. After the introduction of sleep registration technology (polysomnography) better diagnosis and more specific treatment could be offered to patients with sleep disorder health problems. The evaluation of the severity of patient's sleep apnea by polysomnography gives the medical sleep specialist adequate information for a decision which is expected to be optimal for the sleep disorder patient. At Medisch Centrum Molendael the treatment of sleep disorder patients has been focussed on conservative treatment (e.g. weight management, improving sleep hygiene, abstination from alcohol, sedative medications, changing sleep position), removing obstructing tissue, somnoplasty and prescription of oral appliances, depending on the severeness of the health problems.
Although CPAP, positional therapy, weight loss and oral appliances are prescribed frequently to treat sleep disorder health problems, in many studies patient compliance and sometimes side effects are found a major problem. The American Sleep Disorder Association advises the use of oral devices as a “first-choice-therapy” for patients, who snore or exhibit mild sleep apnea and for whom weight management or position therapy have insufficient effect 9.
Oral appliances are divided into two categories—mandibular repositioning devices (MRD) and tongue retaining devices (TRD). Medical indications for oral appliances are:

MRD’s, the most common used devices, increase airway patency by advancing the lower jaw, holding it in a stable position and indirectly pulling the tongue forward. The upper and lower jaws are held closed. TRD’s mentioned in most studies are holding the tongue in an anterior position by attaching a plastic bulb with under-atmospheric pressure at the tongue tip.
Both type of devices have temporary side effects, but in some cases irreversible side effects are reported. TRD’s result in sore tongue tip complaints 11 frequently, while the use of MRD’s stretches the temporomandibular joint (TMJ) and consequently might result in disordered occlusion, reposition of anterior teeth and temporomandibular joint disfunction. In a few occasions remodelling of the TMJ complex occurs, which did lead to failure of repositioning the mandible into the glenoid fossa.12-16. Contrary to the foregoing studies, however Hoekema et al 17 found minimal mandibular and dentogene co-morbidity.
Due to the reported side effects and patient discomfort, our preferred choice for patient treatment, when medical indications are in favour for an oral device, is a tongue-retaining device, which keeps the tongue in normal position, preventing the tongue falling backwards narrowing or closing the airway. Mostly, the tongue might fall back into the airway cavities at night when the tonus of tongue muscles is reduced. Schönhofer et al 18 tested a look-a-like in 1997 with less success, however in that device the force of the pelotte to position the tongue was relatively high and more downward, resulting in pushing the tongue downwards. Contrary, in the device of study the depressor force prevents the tongue from falling backwards, resulting in minimal downward pressure on the tongue. This results in a lower force for equal forward positioning of the tongue. Moreover the tongue-retaining device of study supports the palatum molle too. Such a device does not stretch the TMJ complex and avoids tongue tissue at continuous under-pressure, but practises a mild contact of a soft plastic pelotte at the tongue base only.
The aim of this study is to determine the efficacy and compliance of treatment of patients with a tongue-retaining device, which retains the tongue in normal position by a pelotte and prevents airway obstruction and moreover supports the palatum molle too.
Methods
In the period of January 2004 till August 2004, 60 patients having sleep disorder problems like snoring or sleep apnea syndrome had medical indications suitable for a treatment with a palatum molle supporting tongue-retaining device. All patients were subjected to a polysomnographic evaluation during a night visit at Medisch Centrum Molendael to determine objectively the severeness of their sleep disorder. The tongue-retaining device used in the treatments is depicted in Figure 1. These devices are custom made involving measurements of the patient specific mouth cavity and tongue position and making imprints of the maxillary dental structures.
Patients not suitable for treatment with the tongue-retaining device were treated by surgically (invasive) operation (somnoplasty, uvulopharyngopalatoplasty (UPPP) or tonsillectomy or by conservative methods as weight management, position therapy or improving sleep hygiene).
In first quarter 2007 these patients (in total 60) treated with the tongue-retaining device were requested to participate in a study on efficacy and patient comfort. Their findings in using the device were inventoried by means of a questionnaire (patient self-reporting). Four patients of this group could not be located (unknown address). 54 patients responded and returned the questionnaire, while two patients did not react even after a repeat request. Of these 54 patients, 26 (48%) were apnea patients with an AHI≥15 as tested in the sleep laboratory in Baarn (the A-group),(Figure 3). After the tongue-retaining device had been applied for 13 of these apnea patients another nightly polysomnography have been executed to check the effect of wearing the tongue-retaining device on the frequency of apneas.
The other 28 patients not having the apnea syndrome, all exhibit AHI values below 15 ( the B-group),(Figure 3).
The age distribution of both groups of patients is depicted in Figure 2.
The questions of the questionnaire related to the use, efficacy and patient comfort during treatment.
Results
Of all known other studies on oral appliances only 20% involve more than 50 patients 12. This study studied 54 patients.
16 patients of the A-group (61%) and 20 patients of the B-group (71%) were satisfied with respect to both efficacy and comfort. The overall success score amounts 66%,(Figure 4).
All patients were treated in the first half of 2004, while they reported the efficacy and comfort of the device in April 2007. Consequently, the adherence rate is 66% after 3 years. This rate is better than for studies involving MRD’s 20,21, which report adherence rates of only 48% after 2 years and to 62% after 4 years respectively.
Only 2 of the compliant patients did not use the device each night, but only during holidays or several nights per week.
The reasons for termination the use of the tongue –retaining devise of study were:

Besides the patient self report, 13 patients of the A-group ( 50%) were analysed by a sleep registration test again after they used the device several months in order to determine the efficacy of the oral device objectively.
Surprisingly, the use of the oral devices at the four patients who scored “too low effect” in the self-report were determined as very effective by the objective sleep test (reduction of more than 50% of the frequency of apnea). In literature a reduction of AHI values of more than 50% is mentioned as an effective treatment .
The results of the sleep tests of the other nine patients confirmed the self-report results of efficacy (Reduction of AHI-values by more than 50%).
All results are summarized in Table 1.
Table 1 Numbers of patients, which reported Efficacy and Comfort by self-reporting (1), which reported Non-efficacy, notwithstanding having ≥50% reduction of apnea frequency (2) and which reported Non-efficacy/Discomfort (3)

 

 

No of patients

1.
Efficacy and
Comfort
(self-report)

2.
Efficacy (additional) as confirmed by sleep test

3.
Not effective/
Discomfort

 

 

 

 

 

AHI≥15

26

16

3

7

AHI<15

28

20

0

8

 

TOTAL

 

54

 

36

 

3

 

15



Discussion
Due to the reported side effects and patient discomfort in other oral devices, our preferred choice for patient treatment is a tongue-retaining device, which prevents the tongue to move backwards narrowing the airway and furthermore supports the palatum molle. Such a device does not stretch the TMJ complex and prevents occlusional problems. Also, this device avoids tongue tissue at continuous under-pressure, but practises a mild contact of soft plastic pelotte at the tongue base only.
From a group of 54 patients with sleep disorder complaints due to snoring or/and obstructive apnea-hypopnea 74% were treated effectively by the oral device of study. This success percentage is above average compared to literature data. 66% of the patients did adhere in using the oral device even after 3 years, which is better than reported for mandibular reposition devices (MRD)20,21, which report adherence rates of only 62% after 2 years and to 48% after 4 years respectively. Due to the fact that the oral device of study does not stretch the TMJ complex as in MRD and avoids tongue tissue at continuous under-pressure or over-pressure as in other tongue retaining devices, no side effects as bite change, mandibular repositioning, TMJ complex problems and sore tongue tissue were reported. Apparently the design of the device and especially the depressor and its force on the tongue plays a very important role in efficacy and patient comfort as might be concluded by comparing the results of this study and of the study of Schönhofer et al 18.

 

References

 

 

 

 

 

 

Figure 1. Palatum molle supporting tongue-retaining oral appliance 19

 

Figure 2. Age distribution of both patient groups having AHI>15 (striped)and AHI<15(dotted)

 

 

 

 

 


Figure 3. Apnea severity at patients studied

 

Figure 4. Efficacy and comfort results of all patients

 

 

No of patients

1.
Efficacy and
Comfort
(self-report)

2.
Efficacy (additional) as confirmed by sleep test

3.
Not effective/
Discomfort

 

 

 

 

 

AHI≥15

26

16

3

7

AHI<15

28

20

0

8

 

TOTAL

 

54

 

36

 

3

 

15

 

Table 1 Numbers of patients, which reported Efficacy and Comfort by self-reporting (1), which reported Non-efficacy, notwithstanding having ≥50% reduction of apnea frequency (2) and which reported Non-efficacy/Discomfort (3)

Former ENT specialist, Dept. KNO, Medisch Centrum Molendaal, Baarn, The Netherlands (Nowadays: Meander Medisch Centrum, Baarn); to whom all correspondence has to be sent: Patrijslaan 9, 1343 AC Almere, The Netherlands; ronson@xs4all.nl

ENT Specialist, Dept. ENT, Meander Medisch Centrum, Baarn, The Netherlands

Medical Nurse, Dept. ENT Meander Medisch Centrum, Baarn, The Netherlands

Frequently called MRA (Mandibular Repositioning Appliance)

TRD±Tongue Retaining Device

CPAP: Continuous Positive Air Pressure

AHI: Apnea Hypopnea Index= Number of Apneas and/or Hypopneas per hour of sleep
Apnea: Complete airway blockage resulting in complete cessation of respiratory airflow of at least 10 seconds.
Hypopnea: partial airway blockage resulting in more than 50% reduction of respiratory airflow of at least 10 seconds.
At time of the study Health Care Institutes in the Netherlands used AHI-values of over 15 as a pathological situation. Nowadays, AHI-values of more than 10 are considered as pathological.
The American Academy of Sleep Medicine made recommendations for syndrome definition and measurement techniques 10.

Pelotte: a small, special designed plate with curvature

More detailed information: SnurkenApneuResearch or Snurken.be<