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Measuring the therapy-effect of a mandibular repositioning appliance (MRA): A new method.


- candidate number11183
- NTR NumberNTR3303
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-feb-2012
- Secondary IDsP12-08 / NL39098.044.12; METC Twente / CCMO
- Public TitleMeasuring the therapy-effect of a mandibular repositioning appliance (MRA): A new method.
- Scientific TitleTherapy-effect and compliance of an MRA in patients with mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS).
- ACRONYMMRA-study
- hypothesisWe developed an MRA with integrated accelerometer with which we plan to measure the therapy-effect of the MRA, the compliance and the position of the head of the patient.
- Healt Condition(s) or Problem(s) studiedObstructive sleep apnea syndrome
- Inclusion criteria1. 18 years or older;
2. Ability to understand, read and write Dutch;
3. Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30);
4. Eligible for MRA treatment;
5. Minimum of eight teeth in each of the maxillary and mandibular arches to support the MRA and prior acceptance by a dentist as suitable patient for MRA therapy.
- Exclusion criteria1. Temporomandibular joint disorder;
2. Blocked nose;
3. BMI ≥ 30;
4. Restricted mobility of the mandibula;
5. The inability to provide informed consent.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate30-jul-2012
- Target number of participants15
- InterventionsTherapy with a mandibular repositioning appliance. The appliance is equipped with an acceleratorsensor, which can measure vibrations. A polygrafy will also be performed the same night, to record snorring.
Patients are their own controls.
- Primary outcomeSnoring Index (SI): The time the patient is snoring as a percentage of total sleeping time. Measured with the polygraph and the acceleratorsensor.
- Secondary outcome1. Compliance: The compliance is calculated based on the accelerometer data from the MRA. From this data the number of nights and the hours per night the MRA is used can be derived. The measured compliance is then compared to the outcome of the compliance diary;
2. Position of the head of the patient: The position of the head of the patient is calculated based on the accelerometer data from the MRA. We distinguish three positions: supine, right and left. The supine position means that the head of the patient faces the ceiling. The right and left positions mean that the patient is lying respectively on their right and left side of the head.
- Timepoints4 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. M.M.M. Eijsvogel
- CONTACT for SCIENTIFIC QUERIESMD. M.M.M. Eijsvogel
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
University of Twente
- PublicationsN/A
- Brief summaryWe developed a mandibular repositioning appliance (MRA) with an integrated accelerometer for the treatment of mild-to-moderate obstructive sleep apnea syndrome (OSAS). By means of the accelerometer we plan to measure the therapy-effect of the MRA, the compliance and the position of the head. We therefore measure the therapy-effect by means of the amount of snoring (the snoring index (SI)).
- Main changes (audit trail)
- RECORD22-feb-2012 - 9-mrt-2012


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