Explorative study on unobtrusive sleep monitoring technologies: prolonged in-home measuring in the sleep-disordered population (PRISM study)

Polysomnography (PSG) enables to simultaneously monitor a wide variety of
sleep-related physiological signals, including brain activity
(electroencephalography, EEG), eye-movements (electrooculography, EOG), muscle
tone (electromyography, EMG), cardiac activity (electrocardiography, ECG),
nasal and oral airflow, thoracic and abdominal respiratory movement with belts,
and oxygen saturation using pulse oximetry. Despite being the gold standard for
sleep disorder diagnostics since the 1960*s, some limitations of a PSG must be
considered. A PSG requires a minimum of 22 wires attached to the patient and is
performed in an artificial clinical setting, which negatively affects the
patient*s sleeping experience and makes the it prone to first-night effects.
Furthermore, a PSG is often performed over one or two nights and is therefore
unable to capture the night-to-night variability in sleep and symptoms. But
most importantly, the setup requires dedicated facilities, trained experts, and
complex specialized equipment, making cost and access primary barriers.
Although being a fundamental diagnostic tool for sleep assessment, its
restricted availability contributes to the underdiagnosis of sleep disorders.
Recent advances in sleep monitoring techniques offer new opportunities
to accessibly measure sleep. These technologies include wearable EEG,
actigraphy (ACT), photoplethysmography (PPG), and ballistocardiography (BCG).
They have the ability to measure sleep and sleep-related physiological signals
in an unobtrusive manner for prolonged periods at home. Currently, these
monitoring technologies are not widely utilized for the assessment of sleep
since they lack validation in the clinical population. Therefore, in this
study, we aim to research whether it is possible to obtain the same measures of
macrostructural sleep parameters and abnormal sleep behavior with home
monitoring technologies as with a clinical PSG. Furthermore, the study assesses
whether it is possible to capture the night-to-night variability in these
measures, and whether multimodal approaches improve measuring macrostructural
sleep parameters and abnormal sleep behavior.

The aim of this study is to research if the same measures of macrostructural
sleep parameters and abnormal sleep behavior can be obtained with home
monitoring technologies as with a clinical PSG.

This study will be an observational study. The study design was chosen to make
it possible to collect large amounts of data and to investigate the sleep
characteristics of the study population. The design fits the study since the
study aims to research monitoring technologies in a heterogenous patient
population. Participants include patients referred to the Kempenhaeghe Center
for Sleep Medicine with the suspicion of a sleeping disorder.

As part of the routine clinical investigation, first an intake with the
clinical sleep expert will take place. If the patient is scheduled for a
clinical PSG, the patient will be asked to participate in the study. Generally,
there is a waiting period for the clinical PSG of multiple weeks. The sleep of
the patient can be monitored during this waiting period for 7 days using three
monitoring technologies (BCG bed sensor, EEG headband, and ACT + PPG watch) and
a sleep diary. If the waiting period for the clinical PSG is shorter as the
in-home monitoring time, the in-home measures will completed after the clinical
PSG. During the clinical PSG, the three monitoring technologies will be placed
and will record simultaneously with the PSG sensors, while also the sleep diary
is included.

For the patients participating in the study, there are no direct benefits since
the data obtained with the study will not be used for their diagnosis. However,
they will benefit on the long term from increased understanding of sleep
disorder monitoring. Also, the general outcomes of the study will be
communicated with the participants.

The risk of participating in this study is low since there is no use of
investigational products nor are there any interventions in the study.
Participants will only be subject to additional measures, without intervening
with the regular clinical routine. Furthermore, since the in-home monitoring is
done during the waiting period for the PSG, this will also not intervene with
the clinical routine. Anticipated adverse product effects are related to
wearing the products, which might lead to an uncomfortable feeling or skin
irritation whether products are worn too tightly for a prolonged period.