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Self-Reported Versus Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome

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ClinicalTrials.gov Identifier: NCT01284881
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Brief 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.

Condition or disease Intervention/treatment

Detailed 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.

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
Study Start Date : November 2010
Primary Completion Date : July 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Group/Cohort Intervention/treatment
daily wear overnight

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • clinical diagnosis of sleep-disordered breathing
  • started treatment with oral appliances, such as mandibular repositioning appliances

Exclusion Criteria:

  • dental exclusion criteria for MRA
  • medical contra-indications for MRA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284881

Antwerp University Hospital
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ethisch Comité UZ Antwerpen, Ethical Comité Antwerp, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01284881     History of Changes
Other Study ID Numbers: EC 10/42/284
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp:

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases