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

Phase 2

• Conditions: Gastroesophageal reflux disease; heartburn; 10017977

• Registration Number: NL-OMON53443
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 disorder.
• Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified