The 1 Year Follow-up Objective Oral Appliance Compliance

Not Applicable

Completed

• Conditions: Sleep-disordered Breathing
• Interventions: Device: Mandibular Advancement Device

• Registration Number: NCT01533623
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mandibular advancement device treatment	Mandibular Advancement Device	Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices

Primary Outcome Measures

Name	Time	Method
Safety and feasibility of measuring objective mean wearing time	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

Name	Time	Method
therapeutic index	1 year	to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium