The Effect of Positional Therapy on Symptoms of Gastroesophageal Reflux Disease: A Prospective Pilot Study

NCT04500288 | Unknown DMC

• 1 other identifier: IRB20-00150
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease related symptoms are reported by 10-20% of the adult population and of those 50-75% report symptoms during sleep time. The prevalence of nocturnal GERD (nGERD) is estimated to be about 25% in general population. nGERD causes sleep fragmentation, difficulty falling asleep, daytime sleepiness, reduced work productivity and decreased quality of life. Additionally, nighttime gastroesophageal reflux has been associated with increased risk of GERD-related complications such as severe erosive esophagitis, peptic stricture, esophageal ulcer, Barrett's esophagus, and esophageal adenocarcinoma. Furthermore, nocturnal gastroesophageal reflux has been noted to be associated with atypical and extra-esophageal manifestations as well as sleep disturbances. Overall, patients with nocturnal gastroesophageal reflux are more likely to develop a more severe form of GERD. The mainstay of treatment of nighttime gastroesophageal reflux is a proton pump inhibitor (PPI). However, nighttime heartburn is the most common breakthrough symptom in patients with GERD, who failed PPI treatment. Other important therapies for nighttime GERD include, lifestyle modifications, such as elevating the head of the bed, avoiding eating at least three hours before bedtime, maintaining appropriate sleep hygiene and avoiding the right decubitus position. Elevating the upper torso by raising the head of the bed and avoiding the right-lateral decubitus position have been shown to improve nocturnal symptoms. Several studies have shown that sleeping in the left decubitus position decrease esophageal acid exposure by reducing 13-76% of the reflux episodes. Studies have shown that the right decubitus position increases the rate of transient lower esophageal sphincter relaxations (TLESRs) accompanied by acid reflux, as compared with the left recumbent position. Moreover, maintaining the left lateral recumbent position, reduced by 87% esophageal acid exposure and nocturnal symptoms. LEFT is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland. This technology is designed to train patients to sleep on their left side by a gentle vibration signal once it detects that they are sleeping on their back or right side. Thus, this technique may reduce gastroesophageal reflux and thus provides relief of heartburn and regurgitation during sleep time. The purpose of this study is to determine the usefulness of positional therapy, using the LEFT device, as a nonmedical tool to control GERD-related nocturnal symptoms.

Conditions

Gastro Esophageal Reflux

Keywords

Nocturnal Gastroesophageal Reflux Disease; Gastroesophageal Reflux Disease; LEFT Device; Sleep Hygiene

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study is to determine if positional therapy, using the LEFT device, is effective in improving nighttime GERD-related symptoms as measured by GERD symptoms checklist (questionnaire, involves no specific units of measure).

  Patients will undergo positional therapy using the LEFT device for a period of one month

  1 month

Secondary Outcomes (1)

• The secondary outcome of the study is to determine if positional therapy improves quality of sleep and health-related quality of life as measured by Epworth Sleepiness, Scale and Sleep quality, SF-36 and Berlin questionnaires. No units of measure.

  1 month

Study Arms (1)

LEFT Device Arm

EXPERIMENTAL

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

Device: LEFT Device

Interventions

LEFT Device DEVICE

LEFT device is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland.

Also known as: Epworth Sleepiness Scale, Sleep Quality Questionnaire, Berlin Questionnaire, Demographics Questionnaire, SF-36 Questionnaire, GERD symptoms checklist

LEFT Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18 who have proven GERD (with nighttime heartburn at least 3 days a week).
• Agree to undergo sleep positioning therapy.
• Able to read, understand, and complete study questionnaires.
• Have mobile phones with an operating system (Android or iOS) that supports the LEFT device.

You may not qualify if:

• \. Patients who are under the age of 18.

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Gastroesophageal Reflux; Sleep Hygiene

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Health Behavior; Behavior

Study Officials

• Ronnie Fass, MD

  Director, Division of Gastroenterology and Hepatology at Metrohealth MC

  PRINCIPAL INVESTIGATOR

• Abdulfatah Issak, MD

  Gastroenterology Fellow at Metrohealth MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ronnie Fass, MD, FACG, Director, Division of Gastroenterology and Hepatology, Head, Esophageal and Swallowing Center

Model Details: This is a single center prospective Pilot Study

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: August 5, 2020
• Study Start: March 4, 2021
• Primary Completion: May 21, 2023
• Study Completion: May 21, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

US (1)