NL-OMON21478
Recruiting
Not Applicable
Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux
Amsterdam UMC0 sites45 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amsterdam UMC
- Enrollment
- 45
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 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
Outcomes
Primary Outcomes
Not specified
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