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The 2 Year Follow-up Objective Oral Appliance Compliance

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01533623
First received: January 31, 2012
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

The investigators will perform a 2-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. This procedure will be repeated 2 years 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 Intervention
Sleep-disordered Breathing
 Device: Mandibular Advancement Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: The 2 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Safety and feasibility of measuring objective mean wearing time [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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 questionned regarding side-effects of the microsensor.


Secondary Outcome Measures:
  • therapeutic index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity


Enrollment: 51
Study Start Date: November 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533623

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

No publications provided

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
Study First Received: January 31, 2012
Last Updated: February 20, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013