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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular advancement device | Experimental | Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea |
|
| Placebo | Placebo Comparator | Oral appliance identical to the mandibular advancement device without mandibular advancement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular advancement device | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cintia Z Fiori, MsC | Contact | 555130222282 | cintiazfiori@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Denis Martinez, MD, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| Placebo | Device | 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. |
|
|
| 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 |
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 95700-000 | Brazil |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |