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ID
Source
Brief title
Health condition
mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Snoring Index (SI): The time the patient is snoring as a percentage of total sleeping time. Measured with the polygraph and the acceleratorsensor.
Secondary outcome
1. 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.
Background summary
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)).
Study objective
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.
Study design
4 weeks.
Intervention
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.
P.O. Box 50000
M.M.M. Eijsvogel
Enschede 7500 KA
The Netherlands
+31 (0)53 4872628
P.O. Box 50000
M.M.M. Eijsvogel
Enschede 7500 KA
The Netherlands
+31 (0)53 4872628
Inclusion criteria
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.
Exclusion criteria
1. Temporomandibular joint disorder;
2. Blocked nose;
3. BMI ≥ 30;
4. Restricted mobility of the mandibula;
5. The inability to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL3159 |
| NTR-old | NTR3303 |
| Other | METC Twente / CCMO : P12-08 / NL39098.044.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |