The 1 Year Follow-up Objective Oral Appliance Compliance
NCT ID: NCT01533623
Last Updated: 2013-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2012-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
SINGLE
Study Groups
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mandibular advancement device treatment
Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices
Mandibular Advancement Device
Nightly wearing time
Interventions
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Mandibular Advancement Device
Nightly wearing time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Ethisch Comité UZ Antwerpen
principal Investigator
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
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Other Identifiers
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EC 11/41/291
Identifier Type: -
Identifier Source: org_study_id
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