NCT02325089

ORal ApplianCes for sLeep Apnea of the Elderly

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Hypertension
• Cardiovascular Disease

Interventions

Type	Name	Description
DEVICE	Mandibular advancement 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.
DEVICE	Placebo	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.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-12-01
• Completion: 2020-12-01
• First posted: 2014-12-24
• Last updated: 2016-03-03

Locations

2 sites across 1 country: Brazil