Positional Therapy with LEFT Device for Acid Reflux

Overseen By Ronnie Fass, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 month

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new wearable device called LEFT, designed to help people with nighttime acid reflux by encouraging them to sleep on their left side. The device gently vibrates when it detects the user is not on their left side, helping to reduce acid reflux and improve sleep quality. The study focuses on adults who experience frequent nighttime GERD symptoms that disrupt their sleep.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on a nonmedical device for managing symptoms, it might not require changes to your medication regimen.

How does the LEFT Device treatment for acid reflux differ from other treatments?

The LEFT Device treatment is unique because it uses a wearable electronic device to help patients sleep in a specific position (left lateral decubitus) that reduces acid reflux during the night, unlike other treatments that may involve medications or lifestyle changes. ^{1 2 3 4 5}

Research Team

Ronnie Fass, MD

Principal Investigator

Director, Division of Gastroenterology and Hepatology at Metrohealth MC

Abdulfatah Issak, MD

Principal Investigator

Gastroenterology Fellow at Metrohealth MC

Eligibility Criteria

This trial is for adults over 18 with proven GERD who experience nighttime heartburn at least three times a week. Participants must be able to read and complete questionnaires, have a compatible mobile phone, and agree to sleep positioning therapy using the LEFT device.

Inclusion Criteria

I agree to follow sleep positioning therapy.

I am over 18 and have GERD with frequent nighttime heartburn.

Able to read, understand, and complete study questionnaires

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline questionnaires and a 7-day symptom record diary

1 week

1 visit (in-person)

Device Accommodation

Participants are trained on the LEFT device and undergo a 10-day accommodation period

10 days

1 visit (in-person)

Treatment

Participants use the LEFT device for positional therapy to manage GERD symptoms

1 month

1 visit (in-person)

Follow-up

Participants complete post-treatment questionnaires and return the LEFT device

1 week

1 visit (in-person)

Treatment Details

Interventions

• LEFT Device

Trial Overview The study tests the LEFT device, an electronic wearable that trains patients to sleep on their left side using gentle vibrations. It aims to reduce nocturnal acid reflux symptoms in GERD patients by encouraging a specific sleeping position.

Participant Groups

Group I: LEFT Device Arm Experimental Treatment 1 Intervention

Subjects in this arm will wear the LEFT device for 1 month

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux: A Double-Blind, Randomized, Sham-Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Body position and esophageal sphincter pressure in infants. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effect of sleep positional therapy on nocturnal gastroesophageal reflux measured by esophageal pH-impedance monitoring. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Mechanisms of gastro-oesophageal reflux in the lateral decubitus positions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sleeping on a wedge diminishes exposure of the esophagus to refluxed acid. [2022]