Mandibular Advancement Device on Sleep Quality in Obstructive Sleep Apnea Patients

Study Overview
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Brief Summary
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Sleep is an important factor that influences long-term quality of life with known health consequences. Obstructive sleep apnea, the most prevalent disease that disturbs sleep, is considered a public health problem. Treatment with continuous positive airway pressure is cost effective and reverses the clinical consequences but there is a percentage of patients who do not tolerate it or leave it without treatment and with potential future health complications. Mandibular advancement device can be a valid and well tolerated alternative, it is known that it reduces apnea-hypopnea index, but its effect on the improvement of sleep quality is evaluated by polysomnography that interferes with the quality of sleep. There is an ambulatory monitoring device for sleep quality and circadian rhythms, which can register prolonged periods of time, under natural conditions and at a lower cost than a polysomnography. This pilot project assesses whether mandibular advancement device is an effective and well tolerated alternative in the treatment of obstructive sleep apnea to improve the quality of life and sleep in the medium and long term.

Detailed Description
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Design: observational, unicentric prospective. 50 patients / year will be included, for 3 years. The care protocol (evaluation and follow-up) of the multidisciplinary sleep unit will be followed. Demographic and anthropometric data will be collected. The dental status of the temporo-mandibular joint will be assessed. Radiological records, home respiratory polygraphy, ambulatory monitoring device for 7 days , quality of life questionnaires before and after treatment.

Official Title
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Impact of Treatment With Mandibular Advancement Device (MAD) on Sleep Quality in Patients With Obstructive Sleep Apnea (OSA)

Conditions
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Sleep Apnea, Obstructive

Intervention / Treatment
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* Device: mandibular advancement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Obstructive Sleep Apnea Syndrome opt for mandibular advancement device as 1st treatment alternative opt for mandibular advancement device due to intolerance to continuous positive airway pressure Exclusion Criteria: Patient with orthodontics, malocclusion and periodontal or temporomandibular joint disease who, after assessment by dentistry contraindicates it. Central Sleep apnea (more than 50% of central events in the baseline polygraph). Under 18 years old. Pregnancy Comorbidities that can potentially alter sleep architecture. Psychophysical inability to complete questionnaires. Not obtaining informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: mandibular advancement|The multidisciplinary sleep unit assessment and follow-up protocol will be followed for this group of patients based on the Spanish Clinical Practice Guideline of the Spanish Sleep Society (SES) on the use of mandibular advancement devices in the treatment of patients with obstructive sleep apnea|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mandibular advancement device on sleep quality | Tolerability and efficacy of treatment with a mandibular advancement device (MAD) on sleep quality in patients with Obstructive Sleep Apnea (OSA) measured by the ambulatory circadian monitoring device. | 3 years | 
| ambulatory circadian monitoring device | To evaluate improvement in sleep quality with mandibular advancement devices measured by fragmentation and stability of sleep by the circadian monitoring sensor. | 3 years | 
| home sleep apnea test | To evaluate the number of residual apneic breaths measured by home home sleep apnea test | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive sleep apnea severity | Evaluate the severity by home sleep apnea test | 3 years | 
| questionnaire SF-12 | multidimensional health related quality of life | 3 years | 
| questionnaire EuroQoL | standardized non-disease specific instrument to describe and value health-related quality of life | 3 years | 
| questionnaire iPAQ | International Physical Activity Questionnaire | 3 years |