Primary Objective: To determine whether or not our newly developed MRA with accelerometer can measure the therapy-effect of the MRA by determining the correlation of the treatment-efficacy of an MRA measured by an integrated accelerometer built in…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Snoring Index (SI), the time the patient is snoring as a percentage of
total sleeping time.
Secondary outcome
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.
Background summary
The diagnosis of Obstructive Sleep Apnea Syndrome (OSAS) is based on the
presence of symptoms (e.g. snoring, sleepiness, fatigue and inattention) and
the apnea-hypopnea index (AHI). Mild (5 < AHI < 15) to moderate (15 < AHI < 30)
OSAS can be treated by means of an MRA which is often the patient*s preferred
treatment. The optimisation of MRA treatment (finding the optimal protrusion)
may require up to 6 months of progressive mandibular advancement and for
assessing the treatment effect a polygraphy is required. Such a polygraphy is
very expensive and time-consuming. Also there is night-to-night variation in
the severity of sleep apnea and a night sleep in the hospital does not give a
good representation of a night sleep in the patient's home environment. In this
study we introduce an MRA integrated with an accelerometer to objectively
measure compliance, position and breathing patterns like snoring in the
patient's home environment.
Study objective
Primary Objective:
To determine whether or not our newly developed MRA with accelerometer can
measure the therapy-effect of the MRA by determining the correlation of the
treatment-efficacy of an MRA measured by an integrated accelerometer built in
the MRA, with the treatment-efficacy measured by a polygraphy and
questionnaires.
Secondary Objective(s):
Determining the compliance of the MRA by comparing its accelerometer data with
the compliance diary.
Determining the effect of head-position on the SI.
Study design
This study concerns a comparative study in which the snore index (SI) measured
by the MRA will be compared with the SI measured by the polygraphy. Patients
can be included in the study at any moment in time, until one month prior to
the end of the study.
Prior to the selection the patient is diagnosed having OSAS by conducting a
polygraphy that is part of the regular diagnostic process and will be used as a
base line measurement. When patients satisfy inclusion, an MRA will be fitted.
Therapy with the MRA will be applied for one month for this study and
sequentially a second polygraphy is conducted to assess the efficacy of the
therapy. The accelerometer-data from the MRA will also be used to asses the
compliance and position of the head.
Intervention
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-made MRA during
one month. The first two weeks the subject will use the normal MRA, to get used
to the MRA. After the second week an accelerometer will be integrated in the
MRA, with which the compliance can be measured during the third and fourth
week. The accelerometer will also measure the therapy-effect and the position
of the head during the night.
Study burden and risks
Not applicable.
MST, Postbus 50000, t.a.v. Onderzoeksbureau Longgeneeskunde, poli 12 (longfunctieafdeling)
7500 KA Enschede
NL
MST, Postbus 50000, t.a.v. Onderzoeksbureau Longgeneeskunde, poli 12 (longfunctieafdeling)
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
* 18 years or older.
* Ability to understand, read and write Dutch.
* Diagnosis of symptomatic mild or moderate OSAS (5 < AHI < 30).
* Eligible for MRA treatment.
* 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
- Temporomandibular joint disorder.
- Blocked nose
- BMI >= 30
- Restricted mobility of the mandibula
- The inability to provide informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39098.044.12 |