The 2 Year Follow-up Objective Oral Appliance Compliance
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.
|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|
- 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.
- 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
|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)|
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
This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).