LEFTSTYLE advice for nocturnal reflux symptoms

Gastroesophageal reflux disease (GERD) is one of the most common
gastro-intestinal disorders with an estimated prevalence
of 7%-33% worldwide and results in a major burden on the health care system
given medical visits, costs of treatments and loss
of work productivity. Treatment of GERD in general consists of lifestyle
changes, acid-suppressive medication and sometimes
surgery, depending on the severity of the disease. However, a large proportion
of patients with reflux disease remain under
treatment at the GP or help themselves with self-care advice in which lifestyle
advice and acid suppression are the cornerstone
of the treatment.

It has been shown that body position during sleeping has an effect on nocturnal
gastroesophageal reflux. A technique to reduce
gastroesophageal reflux is to use gravity to prevent the acidic gastric content
going up into the esophagus. Sleeping with an
extra pillow or raising the head-end of the bed is a simple technique often
advised to patients to reduce nocturnal reflux
episodes. Furthermore, it is well established that sleeping in a left lateral
decubitus position reduces reflux occurrence during
nighttime. When sleeping in a left lateral decubitus position, the stomach is
positioned below the esophagus, resulting in less
reflux episodes. Electronic sleep position training devices have already been
proven in patients with sleep apnea and excessive
snoring, in which patients are trained by means of vibration to turn from the
back to the left or right side. By adapting this
device*s vibration/position threshold, it is also possible to train patients to
lie on their left side, thereby reducing nocturnal reflux.
Positional therapy may thus provide a simple, cheap and effective in the
treatment of GERD.

We have recently started a similar study, called LEFT, known to you under
number NL71355.18.19. A large proportion of the patients who experience
nocturnal reflux complaints will look on the internet for advice, buy over the
counter acid suppressive mediation or will visit the general practitioner for
advice. We hypothesize the LEFT device is well-suited for these patients with
moderate reflux symptoms.

The main objective of the study is to investigate if sleep positional therapy,
using the LEFT, reduces nighttime gastroesophageal reflux symptoms.

A single center, prospective, randomized, double blind, sham-controlled trial.

The LEFT is a wearable device attached to the upper chest before patients go to
bed using double sided self-adhesive tape and helps patients with nocturnal
reflux complaints to sleep more on their left side. The LEFT will gently
vibrate when the body is in the *wrong* sleep position (right side position) so
it conditions people to roll over to the left side. The sham group will consist
of an identical device but programmed with different software that does not
vibrate(only the first 20-30 minutes); patient will only receive sleep advice
(sleep on your left side).

Electronic sleep position training devices have already been proven in patients
with sleep apnea and excessive snoring, in which patients are trained by means
of vibration to turn from the back to the left or right side. This opens up the
airway resulting in a significant reduction in snoring and sleep apnea
episodes. The LEFT is adapted version from the SNOOOR; a small, lightweight,
non-invasive and affordable anti-snoring wearable device.

The SNOOOR is used for positional therapy in patients who only snore when they
sleep on their back (supine). The device is placed, with a self-adhesive
sticker, on the forehead or the chest of the patient. It trains patients to
sleep on their side or their head tilted sideways, opening the airway and
reducing or eliminating the snoring. Similar electronic position trainers have
been proven effective in reducing sleep apnea episodes and snoring. Increasing
evidence has showed that active positional therapy may play a role in the
treatment of nocturnal gastroesophageal reflux. A simple modification to the
device, now known as LEFT, has changed it into a possible anti-reflux device.
Given that GERD is considered a disease while snoring is not, the LEFT is a
medical device while the SNOOOR is not.

The burden of participating patients will be one hospital visit and filling out
questionnaires about reflux symptoms (not psychologically stressful). For
patients randomized to LEFT, sleep quality may be disturbed in the first nights
due to the vibrations when they turn towards the *wrong* position in their
sleep. However, after a couple of nights, patients will sleep more and more in
the correct position (left side) and there will be hardly any vibrations
anymore.

In conclusion, positional therapy using LEFT may thus provide a simple, cheap
and effective in the treatment of nocturnal gastroesophageal reflux symptoms.
There are no potential issues of concern.