ORal ApplianCes for sLeep Apnea of the Elderly

Study Overview
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Brief Summary
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Sleep apnea involves significant increases in disease and death, but its consequences in people over 65 years of age are incompletely recognized. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. The investigators hypothesized that oral appliances provided to the elderly may prevent hypertension and other consequences of sleep apnea in large populations, at a favorable cost/benefit relationship for the public health system.

Detailed Description
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Sleep disorders involve significant increases in morbidity and mortality, particularly in those over 60 years. Sleep apnea is the leading identifiable cause of hypertension, which is the main cause of cardiovascular disease. Some degree of sleep apnea is present in up to 95% of the elderly. Intraoral mandibular advancement appliances reduce the number of apneas and hypopneas. We hypothesized that reducing the number of sleep apnea events through oral appliances is effective in preventing high blood pressure and other consequences of sleep apnea in the elderly in the public health system setting. In this superiority parallel, randomized, and double-blinded study we will compare the effect of an intraoral appliance with mandibular advancement to a placebo device without mandibular advancement in preventing high blood pressure and other consequences of sleep apnea in the elderly. The duration of intervention will be of 12 months, with assessments at three, six months, and 12 months.

Official Title
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Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study

Conditions
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Obstructive Sleep Apnea, Hypertension, Cardiovascular Disease

Intervention / Treatment
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* Device: Mandibular advancement device
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mandibular advancement of at least 3 mm Mouth opening of at least 30 mm Sleep apnea with apnea-hypopnea index between 10 and 50 events/hour Agree to participate in the study by signing the informed consent Exclusion Criteria: Already in treatment for sleep apnea Self-reported severe or terminal Illness Physical disability Inability to communicate verbally Dementia in the Mini-Mental State Examination Plan to move to a different a city or to be institutionalized in the next year Participation in another clinical trial Less than eight teeth, periodontal disease, or TMJ problems

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mandibular advancement device<br>Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea | Device: Mandibular advancement device<br>* Use of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea.<br>* Other names: MAD;|
| Placebo Comparator: Placebo<br>Oral appliance identical to the mandibular advancement device without mandibular advancement | Device: Placebo<br>* Placebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year.<br>* Other names: Placebo device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Pressure Monitoring (ABPM) | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference | The NCEP ATP III panel defined metabolic syndrome as the presence of three or more of the following risk determinants: 1) triglyceride levels > to 150 mg / dl; 2) HDL-cholesterol < 40 for men and < 50 for women; 3) glucose > to 110 mg / dl; 4) blood pressure: Systolic > 130 mmHg and / or diastolic blood pressure > 85 mm Hg; 5) waist circumference > 88 cm in women and > 102 cm in men. | 12 months | 
| Composite measure of Physical Ability | The following areas will be evaluated: 1) functional capacity (six-minute walk test), 2) balance (Berg balance scale: 14-item scale designed to measure balance of the older adult in a clinical setting.), 3) flexibility (Wells Sit and Reach Test), 4) mobility (timed up and go test), 5) Force-Velocity Characteristics of Upper and Lower Limbs (Handgrip strength testing: upper, and Sit-to-stand test: Lower), 6) Recall of falls in the last six months | 12 months | 
| Composite measure of Pain | The pain assessment will be conducted by the following methods: 1) Profile of Chronic Pain 2) Assessment of Pain Catastrophizing | 12 months | 
| Quality of life measured by WHOQOL | The patients will answer the WHOQOL-Old module with 24 questions and the WHOQOL-Brief with 26 questions | 12 months | 
| Circadian rhythm | Munich Chronotype Questionnaire | 12 months | 
| Composite measure of Cognitive function | 1) Mini Mental State Examination (MMSE); 2) Digit Span Test, 3) Verbal Fluency Test, 4) The Rey Auditory-Verbal Learning Test, 5) The Boston Naming Test, 6) Trail Making Test, 7) Stroop Color and Word Test, 8) Benton Visual Retention Test (is an assessment of visual perception, memory, and visuo-constructive abilities), 9) Beck Anxiety and Depression Inventory, 10) SYMPTOM CHECK LIST 90R- SCL90-R. | 12 months | 
| Ophthalmological assessment | Retinal and choroidal changes | 12 months | 
| Heart rate variability | Heart rate variability (HRV) The following HRV indices will be calculated in time and in frequency domains using 5-min segments as recommended by the European Society of Cardiology and North American Society of Pacing and Electrophysiology: the mean of all normal RR intervals (mean RR), the root mean square of successive differences of normal adjacent RR intervals (rMSSD), the low-frequency component (LF, 0.04 - 0.15 Hz) and the high-frequency component (HF, 0.15 - 0.5 Hz). | 12 months | 
| Cost-utility analysis measured by QALY | Quality adjusted years of life (QALY) obtained by the intervention will be calculated. | 60 months | 
| Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | 3 months | 
| Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months | 24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Obstructive Sleep Apnea, Mandibular advancement oral appliance, Hypertension, Cardiovascular disease, Quality of life