EFTSTYLE advice for nocturnal reflux symptoms
Phase 3
Completed
- Conditions
- gastroesophageal reflux disease10017977
- Registration Number
- NL-OMON49851
- Lead Sponsor
- Academisch Medisch Centrum
- 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 <p>Treatment success: defined as a 50% reduction in Nocturnal GERD Symptom<br /><br>Severity score from baseline (N-GSSIQ). We considered a 50% reduction in<br /><br>severity score as clinically significant. </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Nocturnal reflux free nights (measured by symptom diary on daily basis - one<br /><br>question)<br /><br>• Change in reflux symptoms (measured by RDQ & symptom diary)<br /><br>• Change in nocturnal reflux symptoms (measured by N-GSSIQ questionnaire and<br /><br>symptom diary)<br /><br>• Change in work productivity (measured by WPAI-GERD questionnaire).<br /><br>• Change in sleep position during study (supine, prone, left lateral decubitus<br /><br>or right lateral decubitus).<br /><br>• Global assessment of treatment on nocturnal reflux symptoms (** Compared to<br /><br>the start of the treatment, how would you rate your nocturnal reflux symptoms<br /><br>now?**)</p><br>