The main objective of the study is to assess the effect of sleep positional therapy, using the LEFT device, on nocturnal gastroesophageal reflux.
ID
Bron
Verkorte titel
Aandoening
Reflux disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in total nocturnal acid exposure time during pH-impedance studies
Achtergrond van het onderzoek
Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders with an estimated prevalence of 7%-33% worldwide and results in a major burden on the health care system given medical visits, costs of treatments and loss of work productivity (1). Treatment of GERD in general consists of lifestyle changes, acid-suppressive medication and sometimes surgery, depending on the severity of the disease. However, a large proportion of patients with reflux disease remain under treatment at the general practitioner or help themselves in which lifestyle advice and over the counter acid suppressive medication.
It has been shown that body position during sleeping has an effect on nocturnal gastroesophageal reflux. When sleeping in a left lateral decubitus position, the stomach is positioned below the esophagus, resulting in less reflux episodes. The efficacy of electronic sleep position training devices have already been proven in patients with sleep apnea and excessive snoring, in which patients are trained by means of vibration to turn from the back to the left or right side (2, 3). By adapting the vibration/position threshold of such a device, it is also possible to train patients to lie on their left side, thereby reducing nocturnal reflux. Positional therapy may thus provide a simple, cheap and effective in the treatment of GERD.
Doel van het onderzoek
The main objective of the study is to assess the effect of sleep positional therapy, using the LEFT device, on nocturnal gastroesophageal reflux.
Onderzoeksopzet
Baseline and after 2 weeks of treatment.
Onderzoeksproduct en/of interventie
The LEFT is a wearable device worn on the upper chest and helps patients with nocturnal reflux complaints to sleep more on their left side. The LEFT will gently vibrate when the body is in the “wrong” sleep position (right side position).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
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NTR-new | NL8657 |
Ander register | METC AMC : METC2020_220 |