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ORal ApplianCes for sLeep Apnea of the Elderly

NCT02325089 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-03-03

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

    collaborator OTHER

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Denis Martinez, MD, PhD · Federal University of Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-12-31
Completion
2020-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02325089 on ClinicalTrials.gov