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The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients

NCT01004692 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2009-10-30

No results posted yet for this study

Summary

Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in obstructive sleep apnoea patients.

Objective: To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening be taken into consideration in daily dental practice, when an occlusal stabilization splint (OSS) is placed in the mouth.

Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18 years old.

Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index (AHI) and the Epworth Sleepiness Scale (ESS).

The aim of this study is to determine the effect of vertical dimension of OS on sleep and respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an increase of the vertical dimension will result in a significant increase in the AHI.

Conditions

Interventions

DEVICE

Occlusal splints

The splint will be a hard acrylic-resin stabilization appliance to wear in the upper jaw. The OSS does not come in contact with the gums of the patient and does not act as an orthodontic device. The OSS will be used only for the three nights in a row, of the ambulatory-PSG recording with the OSS in situ.

Sponsors & Collaborators

  • Academic Centre for Dentistry in Amsterdam

    lead OTHER

Principal Investigators

  • Frank Lobbezoo, professor · Academic Centre for Dentistry in Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-01-31
Completion
2010-06-30

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 NCT01004692 on ClinicalTrials.gov