gastroesophageal reflux disease
Conditions
Interventions
The LEFT is a wearable device attached to the upper chest before patients go to
bed using double sided self-adhesive tape and helps patients with nocturnal
reflux complaints to sleep more on their l
patient will only receive sleep advice
(sleep on your left side).
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Written informed consent. • Both male and female patients will be included. • Age above 18 years. • Symptoms of heartburn and/or acid regurgitation at least 3 times a week during the night. • A total reflux symptom score >=8 (measured through the GERDQ questionnaire score).
Exclusion criteria
Exclusion criteria: • Nightshift workers • Surgery of the esophagus or stomach. • Regular use of sleep medication (benzodiazepines) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success: defined as a 50% reduction in Nocturnal GERD Symptom Severity score from baseline (N-GSSIQ). We considered a 50% reduction in severity score as clinically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Nocturnal reflux free nights (measured by symptom diary on daily basis - one question) • Change in reflux symptoms (measured by RDQ & symptom diary) • Change in nocturnal reflux symptoms (measured by N-GSSIQ questionnaire and symptom diary) • Change in work productivity (measured by WPAI-GERD questionnaire). • Change in sleep position during study (supine, prone, left lateral decubitus or right lateral decubitus). • Global assessment of treatment on nocturnal reflux symptoms (** Compared to the start of the treatment, how would you rate your nocturnal reflux symptoms now?**) | — |
Countries
Netherlands
Outcome results
None listed