Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux

Recruiting

Conditions: Reflux disease

Registration Number: NL-OMON21478

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

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 2 times a week during the night.
-A total reflux symptom score =8 (measured through the GERDQ questionnaire score).
-Minimal of 1.5% esophageal acid exposure during the night.

Exclusion Criteria

-Surgery of the GI tract other than appendectomy or cholecystectomy.
-Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. H2-blockers, antidepressants, prokinetics).
-History of gastrointestinal cancer.
-Known diabetes.
-Regular use of sleep medication (benzodiazepines) that cannot be stopped.
-Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders).
-Pregnant or lactating women. Women will be asked if they are pregnant.
-Patients that sleep >75% of Total Sleep Time (TST) on their left side
-Patients that sleep <10% of TST on their right side

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total nocturnal acid exposure time during pH-impedance studies

Secondary Outcome Measures

Name	Time	Method
-Change in number of nocturnal gastroesophageal reflux episodes (both mixed/liquid reflux episodes and both acidic and non-acidic episodes)<br>-Esophageal acid clearance time.<br>-Sleep position during study (supine, prone, left lateral decubitus or right lateral decubitus).<br>-Relation between sleep positions and reflux parameters.<br>-Frequency of reflux symptoms during the night (measured by symptom diary and pH-measurement).<br>-Questionnaires:<br>o GERDQ questionnaire<br>o Reflux Disease Questionnaire (RDQ) score<br>o The Pittsburgh Sleep Quality Index (PSQI)<br>o Nocturnal Gastroesophageal Reflux Disease (GERD) Symptom Severity and Impact Questionnaire (N-GSSIQ).<br>o Global assessment of treatment success.