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The 1 Year Follow-up Objective Oral Appliance Compliance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01533623
First received: January 31, 2012
Last updated: June 19, 2013
Last verified: June 2013

January 31, 2012
June 19, 2013
Not Provided
July 2012   (final data collection date for primary outcome measure)
Safety and feasibility of measuring objective mean wearing time [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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.
safety and feasibility of measuring objective mean wearing time [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
to assess the safety and feasibility of measuring objective mean wearin time as a measure of objective oral appliance wear
Complete list of historical versions of study NCT01533623 on ClinicalTrials.gov Archive Site
therapeutic index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity
therapeutic index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
to calculate the therapeutic index based on objective compliance and decrease in AHI / disease severity
Not Provided
Not Provided
 
The 1 Year Follow-up Objective Oral Appliance Compliance
The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial

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.

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

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Sleep-disordered Breathing
Device: Mandibular Advancement Device
Nightly wearing time
Other Name: RespiDent Butterfly® Mandibular Repositioning Appliance
mandibular advancement device treatment
Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices
Intervention: Device: Mandibular Advancement Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01533623
EC 11/41/291
No
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
University Hospital, Antwerp
Not Provided
Not Provided
University Hospital, Antwerp
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP