Hypertension Clinical Trial
Official title:
Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
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