The 1 Year Follow-up Objective Oral Appliance Compliance

Sleep-disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533623
• Other study ID #: EC 11/41/291
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: June 19, 2013
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep-disordered Breathing

Intervention

Device:
• Mandibular Advancement Device
Nightly wearing time

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and feasibility of measuring objective mean wearing time	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.	1 year	Yes
Secondary	therapeutic index	to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity	1 year	No