Wearable device eases patients with GERD into left-side sleeping

For patients with gastroesophageal reflux disease (GERD), sleeping on the left side is ideal and alleviates nocturnal reflux symptoms. A wearable device can train these patients to sleep in the ideal position, as shown in a study.

Small and lightweight, the electronic sleep positional therapy wearable device integrates a three-axis accelerometer. The device registers the sleep position at 30-second intervals and categorizes position as supine (back), right, left, prone (belly), and upright. If the user is sleeping on their right side (ie, where the stomach is positioned above the oesophagus, resulting in more reflux), the device vibrates with the intention of stimulating the user to roll over to their left.

“The efficacy of electronic sleep position training devices has already been proven in patients with sleep apnoea and excessive snoring. [These] patients … can be trained by means of vibration to turn from the back to the left or right side,” according to a team of researchers from the University Medical Centers Amsterdam in the Netherlands. [J Clin Sleep Med 2017;13:813-824]

“By adapting the vibration/position threshold of such a device, we assumed it to be possible to train patients suffering from nocturnal reflux symptoms to sleep on their left side, thereby reducing their complaints,” they said.

Zapped into the ideal sleep posture

In a randomized, sham-controlled trial, 100 GERD patients (average age 52 years, 63 percent women) experiencing nocturnal symptoms were advised to sleep on their left side. They were instructed to place the device on their chest with an adhesive sticker and activate it by pressing the power button on the device when going to bed.

In active mode, the device was programmed to produce a vibration when the user in the right lateral position (intervention arm, n=50). In sham mode, the same vibration setting was applied but only during the first 20 minutes of the night. The device was turned off manually or automatically after 8 hours.

The total duration of the study was 5 weeks (2 weeks baseline measurement, 1 week training, and 2 weeks treatment). At baseline, the patients slept in three major positions—supine (intervention: 28.1 percent; sham: 29.5 percent), left side (intervention: 33.2 percent; sham: 31.9 percent), and right side (intervention: 31.3 percent; sham: 30.6 percent).

After 2 weeks of treatment, significantly more patients in the intervention than the sham arm achieved treatment success (44 percent vs 24 percent; p=0.03). This outcome was defined as a ≥50-percent reduction in the nocturnal reflux (N-GSSIQ) score. [Clin Gastroenterol Hepatol 2022;doi:10.1016/j.cgh.2022.02.058]

For the most part, the active intervention helped patients to avoid sleeping on their right side compared with sham (2.2 percent vs 23.5 percent; p<0.0001). It also led to an increase in time spent sleeping on the left side (60.9 percent vs 38.5 percent; p<0.0001).

Finally, the intervention arm had more reflux-free nights compared with the sham arm (9 vs 6 nights; p=0.01). This effect was observed immediately, at the first night of the training week, and was maintained throughout the training and the treatment periods.

Promising addition to GERD treatment toolbox

“These findings indicate that sleep positional therapy should be considered as an addition to the therapeutic armamentarium for patients with nocturnal reflux symptoms,” the researchers said.

“Although total sleep quality did not improve, patients in the intervention group experienced fewer sleep disturbances compared to the sham group. Our findings also underpin the tolerability of positional therapy wearable device, [as] only one patient from the intervention group withdrew from the clinical trial, and we observed no adverse events,” they added.

Having one more option in the treatment of nocturnal reflux symptoms is a boon, the researchers pointed out, as these symptoms negatively affect sleep quality and are associated with more severe reflux disease phenotypes, including erosive reflux esophagitis, Barrett’s oesophagus, and oesophageal cancer. [J Gastroenterol 2012;47:760-769; N Engl J Med 1999;340:825-831; Ann Surg 1976;184:459-470]

Nocturnal reflux symptoms are often managed with lifestyle changes, such as raising the head-end of the bed and prolonging dinner-to-bed time, which do not provide sufficient relief. On the other hand, the use of proton pump inhibitors (PPIs), while very effective for daytime symptoms, have limited efficacy for nocturnal reflux symptoms.

Therefore, the electronic sleep positional therapy wearable device can be used as a complementary treatment for patients that still experience burdensome reflux symptoms despite PPI treatment, the researchers stated.

“Indeed, the benefit of the therapy was mainly observed in patients on PPI (no difference in outcome among participants off PPI). On the other hand, positional therapy might also lead to a reduction in PPI use. The latter hypothesis should be confirmed in subsequent clinical studies,” they added.