The 1 Year Follow-up Objective Oral Appliance Compliance
Primary Purpose
Sleep-disordered Breathing
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mandibular Advancement Device
Sponsored by
About this trial
This is an interventional basic science trial for Sleep-disordered Breathing
Eligibility Criteria
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
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
mandibular advancement device treatment
Arm Description
Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
therapeutic index
to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity
Full Information
NCT ID
NCT01533623
First Posted
January 31, 2012
Last Updated
June 19, 2013
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT01533623
Brief Title
The 1 Year Follow-up Objective Oral Appliance Compliance
Official Title
The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep-disordered Breathing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mandibular advancement device treatment
Arm Type
Other
Arm Description
Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Device
Other Intervention Name(s)
RespiDent Butterfly® Mandibular Repositioning Appliance
Intervention Description
Nightly wearing time
Primary Outcome Measure Information:
Title
Safety and feasibility of measuring objective mean wearing time
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
therapeutic index
Description
to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
The 1 Year Follow-up Objective Oral Appliance Compliance
We'll reach out to this number within 24 hrs