Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01284881 |
| Other study ID # |
EC 10/42/284 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 26, 2011 |
| Last updated |
January 31, 2012 |
| Start date |
November 2010 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
January 2012 |
| Source |
University Hospital, Antwerp |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Belgium: Ethics Committee |
| Study type |
Observational
|
Clinical Trial Summary
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a
treatment option for sleep-disordered breathing (SDB).
The purpose of this study is to compare active measurement of MRA compliance with patient's
self-report.
Description:
Background Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged
as a conservative treatment option for sleep-disordered breathing (SDB).
Up to this date, no objective method is available to measure compliance during oral
appliance treatment for SDB.
As with CPAP in the early years, the sleep apnea community nowadays has a strong interest in
the objective measurement of oral appliance use and adherence. Subjective measures and
self-report commonly result in overestimation of compliance.
Methods We will perform a 12-week clinical trial comparing active/objective measurement of
compliance with subjective self-reported usage.
We will enroll 50 patients with an established diagnosis of SDB that received treatment with
a titratable, duobloc MRA (RespiDent Butterfly® MRA, RespiDent, Nijlen, Belgium).
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Oostenrijk) are
provided by the Handelsagentr Gschladt (Hargelsberg, Oostenrijk) 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.
The microsensors are intercalated into the MRA devices by the dental technician.
Participants receive explanation to the purpose of the study, in the fact that the
investigators want to study temperature fluctuations during the night in the oral cavity. As
a result, the subjects are unaware that their MRA use and compliance is being measured.
A first follow-up appointment is scheduled after the first 4 weeks. A second and final
follow-up visit is scheduled again 12 weeks after the start of the study.
During each follow-up visit patients are asked to fill out a questionnaire containing
questions about MRA wear during the last 4 or 8 weeks (mean hours/night, mean nights/week),
respectively. The objective measurement of MRA 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 MRA has been worn when the chip records a temperature intraorally.
This study design will provide a 12-week evaluation of all patients (n=50).
Perspective and Hypothesis The removable nature of an oral appliance warrants an objective
assessment of the effective use and compliance with overnight MRA treatment for SDB.
We hypothesize that objective compliance might turn out to be significantly lower compared
to the subjectively reported compliance.
