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

Therapy-effect and compliance of an MRA in patients with mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26447

Enrollment

Registered

2012-02-22

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS)

Interventions

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 snorr

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Snoring Index (SI): The time the patient is snoring as a percentage of total sleeping time. Measured with the polygraph and the acceleratorsensor.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactM.M.M. Eijsvogel

Medisch Spectrum Twente, Department of Pulmonology, P.O. Box 50000

+31 (0)53 4872628

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)