Prospects of mandibular advancement device (MAD) as a preferred treatment of obstructive sleep apnea in India: a systematic review

Abstract

Obstructive sleep apnea (OSA) is an independent risk factor for increased cardiovascular and cerebro-vascular morbidity and mortality. OSA leads to loss of human life and huge economical burden to our Society worldwide. The adult’s prevalence of OSA ranges between 9.3-13.5% in India. India is the second largest populated country of the world and by the end of 2030 it may become the most populated nation. This developing nation is already known as the world’s capital of T2 DM, and other non-communicable diseases like Obesity, Hypertension, Stroke, Ischemic heart diseases (IHD), Hypercholesterolemia congestive heart failure are on a rising trend. These cardiovascular disorders were found to be associated with OSA. OSA treatment may improve these co-morbid conditions. Continuous positive airway pressure (CPAP) is a preferred choice for OSA treatment in western and developed countries. In India, where CPAP is out of the reach of most of the OSA affected population due to high cost and other socio-economic and cultural factors, MAD may become a preferred treatment option. MAD is cheaper than CPAP and generally equally effective. The patients suffering from sleep-related breathing disorder (SBD) may have an alternative to CPAP or surgery for their disease management. Mandibular Advancement Device (MAD) may become an additional standard treatment of OSA in India, and has great potential for reducing associated undesirable cardiovascular co-morbidities and mortalities. This review highlights the prospects of MAD as a preferred treatment of Obstructive Sleep Apnea in India by extensively researching scientific literature, PubMed, Google Scholar, scientific, and academic web portals.

Keywords: Hypertension, mandibular advancement device, obesity, obstructive sleep apnea, stroke
Key messages: In India, T2 DM, Hypertension, Stroke, and Ischemic heart diseases are on a rising trend. As these diseases are associated with OSA, and CPAP is out of the reach of most of the OSA affected Indian population due to socio-economic factors, MAD may become a preferred treatment option for treating OSA and reducing cardiovascular morbidities.

How to cite this article:
Dubey A, Kant S, Bajaj DK, Singh BP. Prospects of mandibular advancement device (MAD) as a preferred treatment of obstructive sleep apnea in India: a systematic review. Ann Trop Med Public Health 2017;10:1-6
How to cite this URL:
Dubey A, Kant S, Bajaj DK, Singh BP. Prospects of mandibular advancement device (MAD) as a preferred treatment of obstructive sleep apnea in India: a systematic review. Ann Trop Med Public Health [serial online] 2017 [cited 2017 Jun 6];10:1-6. Available from: https://www.atmph.org/text.asp?2017/10/1/1/205552
Introduction

OSA is an established risk factor for increasing cardiovascular and cerebro-vascular morbidity and mortality. India is known for very high prevalence of T2DM, Hypertension, Stroke, and Ischemic heart diseases. These cardiovascular disorders are linked with OSA. OSA treatment may recover these associated disease conditions.

MAD is cheaper than CPAP and generally equally effective. MAD has great potential for reducing OSA associated adverse cardiovascular morbidities and mortalities in Indian OSA patients. This review highlights the prospects of MAD treatment of OSA in India by researching scientific literature, PubMed, Google Scholar, scientific, and academic web portals.

Epidemiology

OSA is characterized by loud snoring, witnessed breathing interruptions, awakenings due to gasping or choking , periodic reduction, cessation of breathing due to narrowing of the upper airways during sleep, resulting in nocturnal hypoxemia, arousals, excessive day time sleepiness (EDS), and other relatedsymptoms.[1],[2] OSA is an independent risk factor for adverse cardiometabolic profile, and it has been associated with increased cardiovascular and cerebro-vascular morbidity and mortality.[3] Cognitive dysfunction, impaired work performance, anxiety, difficulties in personal relations, and an increased risk of fatal and non -fatal automobile accidents are some other important health consequences of OSA, which lead to loss of human life and huge economical burden to our Society worldwide.[4] The prevalence rates of OSA in adults ranges between 3-27% in total in different settings and population.[1],[5],[6],[7],[8],[9],[10],[11],[12],[13] [Table 1], [Table 2] The prevalence in men ranges between 3-28% while estimations are nearly half as 2.2-16% in women through large-scale epidemiological studies conducted in different countries including India.[14],[15],[16] [Table 1] The prevalence of OSA in India is three times higher in men as compared to women.[16] The major risk factors for OSA include advanced age, male sex, and obesity.[17],[18]

Table 1: Indian Epidemiology

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Table 2: Worldwide Prévalence

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Disease Burden in India

India is the second largest populated country of the world. At the end of 2030, it is projected to get most populated nation’s tag. According to census 2011, population of India is approximately 1, 21, 01, 93, 422. It consists of 69.2% of population of 15+ age group (15-64 years: 64.3%, 65+ years: 4.9%) with median age of 25.1 years. The average life expectancy has increased from 41 years in 1951-1961 to 61.4 years in 1991-1996 and is projected to reach 72 years by 2030. The bracket of middle age group and middle class is expected to expand with an expansion of population and economy growth in next 10 years. At the end of this decade, middle and old age population of India will achieve a huge figure of more than 1220 million people in total.[19] This will lead to multifold burden of SDB and cardiovascular co-morbidities in Indian population. In a resource-poor nation like India, where there is a lack of awareness of sleep disorders among physicians as well as public, even diagnosis of the condition is a farfetched possibility in the dearth of resources, infrastructure, and trained human resource to carry out sleep studies. Infectious diseases such as malaria, tuberculosis, and HIV/AIDS still remain on top priority for Indian health care system.

In the coming years, the emerging epidemic of obesity including childhood obesity and its consequences are bound to impose dual-burden and pose challenges to the functioning of health services. Obesity is a major risk factor for OSA. Obesity is propelled by adoption of sedentary lifestyle, availability of motorized transport, labor-saving mechanical devices, overuse of laptops and computers, televisions, easy availability of highly refined fats and carbohydrates, and consumption of ad lib fast-food items.

Further, OSA also contributes to development of increased cardiovascular morbidity and mortality[20],[21],[22],[23],[24] [Table 3]. India is already known as the world’s capital of T2 DM. Essential hypertension, obesity, and type 2 diabetes mellitus were found to be most frequently associated with OSA. Tobacco use (Past or present), IHD, hypercholesterolemia congestive heart failure, and atrial fibrillation were also found common in the OSA patients.[25]

Table 3: Consequences of Untreated Obstructive Sleep Apnea

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Definition

The diagnosis of OSA needs the objective manifestation of abnormal breathing during sleep by calculating the respiratory disturbance index (RDI, events per hour of sleep), that is the frequency of apnea (complete upper airway obstruction), hypopnea (partial upper airway obstruction), and arousals from sleep related to respiratory efforts. OSA is defined by combining symptoms and an RDI (≥5) or by an RDI (≥15) without symptoms.[2] The apnea-hypopnea index (AHI), the frequency of apnea and hypopnea events per hour of sleep, is widely used to define OSA. OSA is classified as mild (5-15), moderate (16-30), and severe (>30) based on an average number of apneas and/or hypopneas per hour of total sleep time.

Mandibular Advancement Devices (MAD)

MAD, reposition the mandible and the tongue downward and forward. This way the airway passage is increased first, by the forward positioning of these structures, second, by increasing the tension of the airway muscles. Advancing mechanism is engaged until the patient begins to feel any discomfort in his temporomandibular joint .Other oral appliances (OA) like tongue repositioning devices (TRD) and tongue stabilizing device (TSD) are also used for treatment of OSA. TRD works by pulling only the tongue forward and not the entire lower jaw. The advantage of it is that the teeth, jaw muscles and joints are less affected. TRD has few disadvantages like less chance of success due to inadequate retention during sleep.[26],[27],[28],[29] TSD works by holding the tongue forward by a gentle suction, thus, preventing it from falling back against the back of the throat, keeping the airway open during sleep.[30],[31],[32],[33]

OSA and Insulin Resistance

Epidemiologic studies have demonstrated that OSA is associated with insulin resistance and glucose intolerance, independent of obesity.[34],[35],[36] Clinical investigations have also shown that OSA results in low-grade systemic inflammation.[37],[38] Both insulin resistance and systemic inflammation may contribute to the increased cardiovascular risk in patients with OSA.[39],[40],[41] Insulin resistance, systemic inflammation, and OSA are particularly prevalent in patients with severe obesity defined as a body mass index (BMI) exceeding 40 kg/m2.[34],[42],[43],[44] While obesity causes systemic inflammation, insulin resistance, and sleep apnea.[31],[32],[33],[34] It may further exacerbate the inflammatory and metabolic disturbances but previous data showthat weight loss, physical activity and surgical interventions can significantly avert and treat obesity-related coronary heart disease risk factors.[34],[35],[38],[45],[46]

Mandibular Advancement Device (MAD) in Treatment of OSA

MAD treatment of OSA has gained considerable popularity because of its simplicity and supposed reversibility.[47] Total 41 studies satisfied adequate standards of evidence, and addressed the question of efficacy by providing objective sleep data before and after treatment. Ten of them were Randomized well-designed trials with low-α & low-beta errors. There were 5 Level II (Randomized trials with high-beta errors) studies 1 Level III (Nonrandomized controlled or concurrent cohort studies) study and there were 25 Level V (Case series) studies.[48]

Compliance

Although initial side-effects, such as jaw discomfort, tooth tenderness, excessive salivation and/or temporary occlusal changes, were reported in approximately half of the patients even then 76% of the patients continued treatment[49] after one year and 65% were using their devices after 4 years[50] as observed in two different studied. MADs ccompliance has been reported to be superior than with CPAP[51],[52] and MADs are preferred by the patients.[52],[53],[54],[55],[56] The effect on sleepiness was generally parallel between CPAP and MADs.[51],[52],[54],[55],[56],[57] Titratable custom-made MADs have been used in the majority of the efficacy studies. Comparison between device designs indicated that there are only minor differences in treatment effects between custom-made device[58],[59],[60],[61] while a prefabricated device was less effective.[62]

What is lacking?

An assessment of efficacy of treatment of OSA with MAD in terms of metabolic markers, inflammatory markers, and quality of life is lacking while there are numerous studies already in literature about same in CPAP therapy. MAD treatment modality if found effective in these terms may get stronger base to be used for treatment in OSA for prevention of multiple burden of cardiovascular risk associated with OSA. In this way, it may also improve cardiovascular profile as well as disease prognosis and treatment success rate of OSA cases.

Potential role of MAD to existing treatment for OSA and associated co-morbidities

OSA is a multifactor disease with many risk factors related with anthropometrical, biochemical, physiological, and pathological profile of a person. In Indian context SDB; OSA is the most under diagnosed and almost never treated problem due to numerous facts associated with lack of awareness, education, and issues related with socio-economic conditions. Establishment of MAD as core and preferred choice treatment for OSA subjects in Indian population may make a remarkable effect.

Currently we do not have any national or international prospective data of metabolic markers, inflammatory markers of MAD intervention in subjects suffering from OSA. We anticipate a positive outcome in MAD intervention as like in case of related published research work in OSA cases with CPAP. Insulin resistance and cardiovascular parameters were found to be improved by the treatment of OSA.[63],[64] It may improve and sustain overall health of this group and will reduce the burden of health care utilities, which are already inappropriate for our population.

Affordability

MAD is the cheapest treatment modality available for treatment of Sleep disorder Breathing (Snoring, Upper airway resistance and Obstructive sleep apnea) in India. It costs around INR 500-1,500/- in development of a MAD which is 50-160 times cheaper than CPAP (Cost INR—25,000-80,000/-)[65] and possibly equally effective. We have sufficient number of well skilled Dental surgeons and Specialist in Dental sciences[66] to treat a large number of patients suffering from OSA. Graduate dentist may also be trained if required, with a short term training module to treat this diseased population in assistance with concern Medical specialist.MAD is a preferred choice[67],[68] of treatment in OSA in regular practice internationally, even then, when MAD development cost is very high in these countries (Approx-1000$; 550 times higher than in India). Various published literature confirms efficacy of MAD in short and long term.

In Indian situations where CPAP is out of the reach of most of the population due to high cost and othersocio-economic factors including electricity supply hindrance in all over India. In these circumstances MAD with life style modification may become an additional standard treatment of OSA in India and may play a vital role in reducing associated undesirable cardio-vascular co-morbidities and mortalities.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

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Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/1755-6783.205552

Tables

[Table 1], [Table 2], [Table 3]

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