ORal ApplianCes for sLeep Apnea of the Elderly (ORACLE)

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Obstructive Sleep Apnea; Cardiovascular Disease

Treatments: Device: Mandibular advancement device; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02325089

140069

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 2 patient groups, including a placebo group

Mandibular advancement device

Experimental group

Description:

Mandibular advancement device titrated to reduce or eliminate snoring and sleep apnea

Treatment:

Device: Mandibular advancement device

Placebo

Placebo Comparator group

Description:

Oral appliance identical to the mandibular advancement device without mandibular advancement

Treatment:

Device: Placebo