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The 1 Year Follow-up Objective Oral Appliance Compliance

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ClinicalTrials.gov Identifier: NCT01533623
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : June 20, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.

The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).

Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.

A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.

The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.

Condition or disease Intervention/treatment
Sleep-disordered Breathing Device: Mandibular Advancement Device

Detailed Description:
This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
mandibular advancement device treatment
Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices
Device: Mandibular Advancement Device
Nightly wearing time
Other Name: RespiDent Butterfly® Mandibular Repositioning Appliance

Outcome Measures

Primary Outcome Measures :
  1. Safety and feasibility of measuring objective mean wearing time [ Time Frame: 1 year ]
    To assess the safety and feasibility of measuring objective mean wearing time as a measure of objective oral appliance wear. The objective mean wearing time will be assessed using a microsensor thermometer. Regular follow-up visits will be performed, and patients will be questioned regarding side-effects of the microsensor.

Secondary Outcome Measures :
  1. therapeutic index [ Time Frame: 1 year ]
    to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of sleep-disordered breathing
  • started treatment with a titratable, duobloc mandibular advancement device
  • participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)

Exclusion Criteria:

  • dental exclusion criteria for mandibular advancement devices
  • medical contra-indications for mandibular advancement devices
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533623

Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
More Information

Responsible Party: Ethisch Comité UZ Antwerpen, principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01533623     History of Changes
Other Study ID Numbers: EC 11/41/291
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes