Measuring the therapy-effect and compliance of a Mandibular Repositioning Appliance (MRA) in patients with mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS).

Measuring the therapy-effect and compliance of a Mandibular Repositioning Appliance (MRA) in patients with mild-to-moderate Obstructive Sleep Apnea Syndrome (OSAS). - Mandibular Repositioning Appliance (MRA) - study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37471

Enrollment

Registered

2012-03-06

Start date

2012-05-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

'OSAS' 'sleep apnea'

Interventions

Each individual receives a custom made MRA with an integrated accelerometer and will sleep with the MRA every night during one month. Subjects who participate in this study will sleep with a custom-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 18 years or older. * Ability to understand, read and write Dutch. * Diagnosis of symptomatic mild or moderate OSAS (5

Exclusion criteria

Exclusion criteria: - Temporomandibular joint disorder. - Blocked nose - BMI >= 30 - Restricted mobility of the mandibula - The inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
The Snoring Index (SI), the time the patient is snoring as a percentage of total sleeping time.	—

Secondary

Measure	Time frame
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. Position: The position of the head of the patient is calculated based on the accelerometer data from the MRA. Apneas: The polygraphy can measure the AHI. With the accelerometer-data that is acquired during the second polygraphy we want to see whether or not we can detect apneas with the MRA. Flow: The polygraphy can measure the airflow during the night. With the accelerometer-data that is acquired during the second polygraphy we want to see whether or not we can detect the presence and absence of airflow with the MRA. Quality of life: Health related quality of life changes in patients with OSAS after MRA-treatment by means of the Quebec Sleep Questionnaire. Tendency to fall asleep: Change in tendency to fall asleep after the MRA-treatment by means of the Epworth Sleepiness Scale. Subjective therapy-effect: Therapy-effect according to the patient and his/her partner by means of the Visual Analogue Scale.	—

Measure

Time frame

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. Position: The position of the head of the patient is calculated based on the accelerometer data from the MRA. Apneas: The polygraphy can measure the AHI. With the accelerometer-data that is acquired during the second polygraphy we want to see whether or not we can detect apneas with the MRA. Flow: The polygraphy can measure the airflow during the night. With the accelerometer-data that is acquired during the second polygraphy we want to see whether or not we can detect the presence and absence of airflow with the MRA. Quality of life: Health related quality of life changes in patients with OSAS after MRA-treatment by means of the Quebec Sleep Questionnaire. Tendency to fall asleep: Change in tendency to fall asleep after the MRA-treatment by means of the Epworth Sleepiness Scale. Subjective therapy-effect: Therapy-effect according to the patient and his/her partner by means of the Visual Analogue Scale.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)