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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01284881
First received: January 26, 2011
Last updated: January 31, 2012
Last verified: January 2012

January 26, 2011
January 31, 2012
November 2010
July 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01284881 on ClinicalTrials.gov Archive Site
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Self-Reported Versus Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample

OSAHS

OSAHS
Device: MRA
daily wear overnight
OSAHS
Intervention: Device: MRA
Dieltjens M, Braem MJ, Vroegop AV, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM. Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest. 2013 Nov;144(5):1495-502. doi: 10.1378/chest.13-0613.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01284881
EC 10/42/284
No
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
University Hospital, Antwerp
Not Provided
Not Provided
University Hospital, Antwerp
January 2012

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