NCT02325089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

2.4 years

First QC Date

October 28, 2014

Last Update Submit

March 1, 2016

Conditions

Obstructive Sleep ApneaHypertensionCardiovascular Disease

Keywords

ElderlyObstructive Sleep ApneaMandibular advancement oral applianceHypertensionCardiovascular diseaseQuality of life

Outcome Measures

Primary Outcomes (1)

  • Arterial Blood Pressure Monitoring (ABPM)

    24-h, diurnal, and sleep systolic and diastolic blood pressure. Systolic and diastolic dipping.

    12 months

Secondary Outcomes (11)

  • Composite measure of Metabolic Syndrome including Glucose, Cholesterol, Triglyceride, Blood pressure, and Waist circumference

    12 months

  • Composite measure of Physical Ability

    12 months

  • Composite measure of Pain

    12 months

  • Quality of life measured by WHOQOL

    12 months

  • Circadian rhythm

    12 months

  • +6 more secondary outcomes

Study Arms (2)

Mandibular advancement device

EXPERIMENTAL

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

Device: Mandibular advancement device

Placebo

PLACEBO COMPARATOR

Oral appliance identical to the mandibular advancement device without mandibular advancement

Device: Placebo

Interventions

Mandibular advancement deviceDEVICE

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.

Also known as: MAD
Mandibular advancement device
PlaceboDEVICE

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.

Also known as: Placebo device
Placebo

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 95700-000, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertensionCardiovascular Diseases

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Denis Martinez, MD, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cintia Z Fiori, MsC

CONTACT

555130222282cintiazfiori@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 28, 2014

First Posted

December 24, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2020

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

BR(2)