Sleep-disordered Breathing
Conditions
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).
Interventions
DEVICEMandibular Advancement Device
Nightly wearing time
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| therapeutic index | 1 year | to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity |
Countries
Belgium
Outcome results
None listed