Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21478

Enrollment

Registered

2020-05-25

Start date

2019-12-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux disease

Interventions

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”

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Change in total nocturnal acid exposure time during pH-impedance studies	—

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactJeroen M. Schuitenmaker

Amsterdam UMC (locatie AMC)

j.m.schuitenmaker@amsterdamumc.nl+31205662199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)