The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.

Gastroesophageal reflux disease (GERD) is one of the most common
gastro-intestinal disorders and approximately 50-80% of the GERD patients
experience nocturnal gastroesophageal reflux symptoms. Symptoms at night have a
negative impact on sleep quality, daytime functioning and quality of life. When
sleeping in left lateral decubitus position, the stomach is positioned below
the esophagus, resulting in less reflux compared to sleeping in right lateral
decubitus position. Sleep positional therapy, using an electronic wearable
device (the LEFT, an adaptation of the SNOOOR device designed to stop snoring),
which gently vibrates when sleeping in the right lateral decubitus position,
promotes sleeping in the left lateral decubitus position and effectively
alleviates nocturnal gastroesophageal reflux symptoms. The aim of our study is
to investigate if sleep positional therapy, using the LEFT smartwatch app, can
reduce nocturnal gastroesophageal reflux symptoms and increase sleeping in the
left lateral decubitus position.

The main objectives of the study are to investigate if sleep positional
therapy, using the LEFT smartwatch app, reduces nocturnal gastroesophageal
reflux symptoms and can train patients to avoid sleeping in right side
position.

Single center, prospective, single-arm, non-blinded, interventional pilot study

The SNOOOR device is worn on the upper chest and is designed to measure sleep
position and stimulate to avoid the supine sleeping position in subjects with
positional snoring. It is normally programmed to vibrate when it measures that
the subject is sleeping on the back, so it stimulates the subject to turn to a
lateral sleep position in order to stop positional snoring. The LEFT is a small
wearable device is the adapted version of the SNOOOR and gently vibrates when
the body is in the right lateral decubitus position. This will train subjects
to sleep in left lateral decubitus position, the position where the stomach is
placed below the esophagus. The LEFT wearable device has been proven to reduce
nocturnal reflux symptoms.

The LEFT smartwatch app is an app on the Apple Watch that works in the same way
as the LEFT wearable device. It will gently vibrates in an annoying way when
the body is in the right lateral decubitus position. All subjects will receive
treatment. In the current study, the SNOOOR wearable device will only be used
as a tracker device. The vibration option will be inactive. In this way, the
device can be used to accurately measure the sleeping body position and these
results can be compared to the results of the LEFT smartwatch app.

The Apple Watch is a clinically validated and CE marked and a medical certified
device. The risks associated with the use of the Apple Watch, like local skin
rash on the wrist, are the same as would be the case if the subject uses the
device outside the study context. An additional risk related to the use of the
LEFT smartwatch app, is the disturbed sleep due to vibrations of the Apple
Watch that will trigger changing position. However, this will only be at the
start of the treatment, because the subject will be trained to avoid sleeping
in the right lateral decubitus position. No irreversible injury or damage to
health is possible related to the use of the LEFT smartwatch app or Apple Watch.

Our study team has previously shown that sleep positional therapy, using an
electronic wearable device (the LEFT wearable device), was effective for
nocturnal reflux complaints without any adverse events. Other studies with
sleep positional therapy for the indication obstructive sleep apnea have
reported that sleep can be disturbed because of the vibrations of the device
and sometimes neck or shoulder pain is reported, but no more adverse events
have occurred.

Subjects have to come to the (online) screening visit and have to fill in
questionnaires. Data of the LEFT wearable device and the Apple Watch will be
extracted from the device. No additional tests or treatments are required. All
subjects receive the Apple Watch for sleep positional therapy and there will be
no placebo group. So, the burden of participate is low compared to the possible
benefits of the sleep positional therapy.