We 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.
ID
Bron
Verkorte titel
Aandoening
mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Snoring Index (SI): The time the patient is snoring as a percentage of total sleeping time. Measured with the polygraph and the acceleratorsensor.
Achtergrond van het onderzoek
We 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)).
Doel van het onderzoek
We 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.
Onderzoeksopzet
4 weeks.
Onderzoeksproduct en/of interventie
Therapy 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.
Publiek
P.O. Box 50000
M.M.M. Eijsvogel
Enschede 7500 KA
The Netherlands
+31 (0)53 4872628
Wetenschappelijk
P.O. Box 50000
M.M.M. Eijsvogel
Enschede 7500 KA
The Netherlands
+31 (0)53 4872628
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Temporomandibular joint disorder;
2. Blocked nose;
3. BMI ≥ 30;
4. Restricted mobility of the mandibula;
5. The inability to provide informed consent.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3159 |
| NTR-old | NTR3303 |
| Ander register | METC Twente / CCMO : P12-08 / NL39098.044.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |