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Oral Appliance Therapy in Obstructive Sleep Apnea

NCT00950495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-12-25

No results posted yet for this study

Summary

The aim of the study was to compare the effects of a mandibular advancement device (MAD) with those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device in obstructive sleep apnea (OSA) patients. The hypothesis for this study was that both MAD therapy and nCPAP therapy have similar, better treatment effects than placebo therapy in OSA. The study was performed according to the CONSORT (consolidated standards of reporting trials) statement (Altman et al., 2001), employing a parallel-group, randomized, placebo-controlled trial design.

Conditions

Interventions

DEVICE

Mandibular Advancement Device (MAD)

This oral appliance keeps the mandible and the tongue in a protruded position. This results in an upper respiratory tract widening and/or reduced collapsibility of the upper airway, thereby preventing the upper airway collapse during sleep.

DEVICE

nasal CPAP

The CPAP machine delivers a stream of compressed air via a hose to a nose mask, splinting the airway (keeping it open under air pressure) so that unobstructed breathing becomes possible, reducing and/or preventing apneas and hypopneas

DEVICE

placebo

as a placebo, a thin (\< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used

Sponsors & Collaborators

  • VU University of Amsterdam

    lead OTHER

Principal Investigators

  • Ghizlane Aarab, DDS · Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2009-01-31
Completion
2009-07-31

Countries

  • Netherlands

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 NCT00950495 on ClinicalTrials.gov