Sleep position trainer versus MRA: a randomised controlled cross-over clinical trial

Obstructive sleep apnea syndrome (OSA) is the most common sleep-related
breathing disorder. Mandibular reposition apparatus (MRA) is the treatment of
choice for mild to moderate OSA, with adherence of 81%. 23-71.4 % of patients
with OSA have a position dependent OSA (POSA). There are several different
definitions of POSA. The one that is used most often and which is most honest,
and posed by Mador is that in which the apnea-hypopnoea index (AHI) in
non-supine sleeping position is less than 5 /h instead of the also used
definition as used by Marklund et al[2, 3]. There have been several treatment
options in the past to adjust the sleep position, however without consistent
success, and mostly because of lack of compliance. Recently several
sleep-position trainers (SPT) have been developed with compact sensors with
actuators that register sleep position accurately and which stimulate the
patient to alter their sleep position using vibration. In POSA a SPT might be
as effective as MRA and the potential treatable group can be larger because 25
% of patients has a contra-indication for MRA because of (peri)dental
disorders.

Primary Objective: Evaluation of effectiveness (AHI using PSG) of SPT when
compared to MRA in patients with mild to moderate positional dependent
obstructive sleep apnea (POSA) in a non-inferiority setting for a short (3
months) and longterm (12 months) evaluation period.

Secondary Objective(s): ODI using PSG, ESS, FOSQ-10, compliance short-term (3
months) and long-term (9 months in case of preference) using sensor (Somnomed
dentitrac / nightbalance), adverse events, therapy responding, Mean disease
alleviation (MDA), total sleep time (TST), sleepposition, total costs and
therapy preference.

A randomized controlled cross-over clinical trial. It*s a mono-center study in
the Center of Sleep Medicine Amphia Hospital Breda/Oosterhout. Patients
assessed and diagnosed by poly(somno)graphy of having mild to moderate POSA
(AHI 6-29/hour). The first group will be treated initially with MRA for a
period of 3 months re-assessed with a PSG and questionnaires for primary
outcome measurement and consecutively using SPT during 3 months and again be
re-assessed with a PSG and above mentioned questionnaires. The other group will
be treated initially with a SPT during 3 months and subsequently for a period
of 3 months with MRA. Follow-up of compliance will be 12 months.

Sleep-position trainer (SPT)

1. 2 polysomnographies extra when compared to standard care (each 1 night).

2. Answering 6 questionairs at a total of 3 timepoints (estimated 13 minutes
for each timepoint):
- ESS at 3 timepoints
- FOSQ at 3 timepoints
- SF36 questionaire at 3 timepoints
- MFIQ at 2 timepoints
- Questionaire SPT at 2 timepoints
- Questionaire MRA at 2 timepoints
- Questionaire patientsatisfaction comparing SPT with MRA at 1 timepoint