NCT01533623

The 1 Year Follow-up Objective Oral Appliance Compliance

The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Sleep-disordered Breathing

Interventions

Type	Name	Description
DEVICE	Mandibular Advancement Device	Nightly wearing time

Timeline

• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-15
• Last updated: 2013-06-20

Locations

1 site across 1 country: Belgium