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

NCT06075082 | Completed DMC

• 1 other identifier: NL83321.018.22
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of the study are (1) to investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gastroesophageal reflux disease symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Conditions

Gastroesophageal Reflux; Heartburn

Keywords

Sleep positional therapy

Outcome Measures

Primary Outcomes (1)

• Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)

  The primary efficacy measure is relative change in total nocturnal gastroesophageal reflux symptoms measured by the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ). The N-GSSIQ is a 20-item questionnaire measuring the severity, morning impact and concern about nocturnal gastro-esophageal reflux disease. The N-GSSIQ is a validated questionnaire to assess nocturnal GERD symptom severity over the past 2 weeks. The N-GSSIQ is comprised of three subscales: Nocturnal Gastroesophageal Reflux Disease Symptom Severity (13 questions, score range 0-65), Morning Impact of Nocturnal Gastroesophageal Reflux Disease (2 questions, score range 0-10), and Concern about Nocturnal Gastroesophageal Reflux Disease (5 questions, score range 0-20). Total score ranging from 0 to 95. A higher score indicates more severe symptoms.

  2 weeks

Secondary Outcomes (7)

• Treatment success

  2 weeks

• Change in total Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score.

  2 weeks

• Sleep position

  2 weeks

• Number of nocturnal reflux free nights

  2 weeks

• Reflux disease questionnaire (RDQ)

  2 weeks

Study Arms (1)

Sleep positional therapy by using the LEFT smartwatch app

EXPERIMENTAL

Device: LEFT smartwatch app

Interventions

LEFT smartwatch app DEVICE

The LEFT smartwatch app is an app on the Apple Watch which measures body sleep position and gently vibrates when the body is in the right lateral decubitus position. In this way, patients with nocturnal gastroesophageal reflux symptoms learn to avoid the right lateral sleep position as they will avoid the annoying vibrations. Measurements while using the smartwatch app will be compared to measurements at baseline.

Sleep positional therapy by using the LEFT smartwatch app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Both male and female patients will be included.
• Age 18 years or older.
• Symptoms of heartburn and/or acid regurgitation during at least three nights a week.
• A total reflux symptom score ≥8 (measured through the GERDQ questionnaire score).
• Able to wear the Apple Watch on the left wrist.

You may not qualify if:

• Complete PPIs non-responders.
• Nightshift workers
• Surgery of the esophagus or stomach.
• Regular use of sleep medication (benzodiazepines) or medication which affect gastrointestinal motility (e.g. prokinetics or opioids) that cannot be stopped during the duration of the trial.
• Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
• Patients with obstructive sleep apnea or esophageal motility disorders.
• Pregnant or lactating women.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. A.J. Bredenoord

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

NL (1)