The 1 Year Follow-up Objective Oral Appliance Compliance
|ClinicalTrials.gov Identifier: NCT01533623|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : June 20, 2013
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||Phase|
|Sleep-disordered Breathing||Device: Mandibular Advancement Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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
- 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.
- therapeutic index [ Time Frame: 1 year ]to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533623
|Antwerp University Hospital|
|Edegem, Antwerp, Belgium, 2650|