EFTSTYLE advice for nocturnal reflux symptoms
Completed
- Conditions
- Reflux disease
- Registration Number
- NL-OMON29495
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment success, defined as a 50% reduction in Nocturnal GERD Symptom Severity score from baseline (N-GSSIQ questionnaire).
- Secondary Outcome Measures
Name Time Method -Nocturnal reflux free nights (measured by symptom diary on daily basis – one question)<br>-Change in reflux symptoms (measured by RDQ & symptom diary)<br>-Change in nocturnal reflux symptoms (measured by N-GSSIQ questionnaire and symptom diary)<br>-Change in work productivity (measured by WPAI-GERD questionnaire).<br>-Change in sleep position during study (supine, prone, left lateral decubitus or right lateral decubitus).<br>-Change in sleep quality (measured by the PSQI questionnaire)<br>-Global assessment of treatment on nocturnal reflux symptoms (‘’ Compared to the start of the treatment, how would you rate your nocturnal reflux symptoms now?’’)