Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux

Phase 2

Recruiting

Conditions: gastroesophageal reflux disease
10017977

Registration Number: NL-OMON52836

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

• Written informed consent.
• 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, antacids).
• 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).
• Patients that sleep >75% of Total Sleep Time (TST) on their left side.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Change in total nocturnal acid exposure time during pH-impedance studies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Change in number of nocturnal gastroesophageal reflux episodes (both<br /><br>mixed/liquid reflux episodes and both acidic and non-acidic episodes)<br /><br>• Esophageal acid clearance time.<br /><br>• Sleep position during study (supine, prone, left lateral decubitus or right<br /><br>lateral decubitus).<br /><br>• Relation between sleep positions and reflux parameters.<br /><br>• Frequency of reflux symptoms during the night (measured by symptom diary).<br /><br>• Questionnaires:<br /><br>o Screening: GERDQ questionnaire<br /><br>o Reflux Disease Questionnaire (RDQ) score<br /><br>o The Pittsburgh Sleep Quality Index (PSQI)<br /><br>o Nocturnal Gastroesophageal Reflux Disease (GERD) Symptom Severity and Impact<br /><br>Questionnaire (N-GSSIQ) (22). </p><br>