Status:
COMPLETED
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Gastroesophageal Reflux
Heartburn
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders and approximately 50-80% of the GERD patients experience nocturnal gastroesophageal reflux symptoms. Sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2024
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06075082
Start Date
October 1 2023
End Date
October 7 2024
Last Update
May 31 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ