Clinical trial NCT02325089: ORal ApplianCes for sLeep Apnea of the Elderly
Official title: Effect of Treating Sleep Apnea With Oral Appliances in the Elderly: ORACLE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Hypertension
Cardiovascular Disease
Keywords: Elderly
Obstructive Sleep Apnea
Mandibular advancement oral appliance
Hypertension
Cardiovascular disease
Quality of life
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-12-24
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Arterial Blood Pressure Monitoring (ABPM)
timeFrame: 12 months
Secondary outcomes:
measure: Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference
timeFrame: 12 months
measure: Composite measure of Physical Ability
timeFrame: 12 months
measure: Composite measure of Pain
timeFrame: 12 months
measure: Quality of life measured by WHOQOL
timeFrame: 12 months
measure: Circadian rhythm
timeFrame: 12 months
measure: Composite measure of Cognitive function
timeFrame: 12 months
measure: Ophthalmological assessment
timeFrame: 12 months
measure: Heart rate variability
timeFrame: 12 months
measure: Cost-utility analysis measured by QALY
timeFrame: 60 months
measure: Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at three months
timeFrame: 3 months
measure: Change from Baseline Arterial Blood Pressure Monitoring (ABPM) at six months
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Denis Martinez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: