LEFTSTYLE advice for nocturnal reflux symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29495

Enrollment

100

Registered

2020-05-25

Start date

2020-04-26

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 attached to the upper chest before patients go to bed using double sided self-adhesive tape and helps patients with nocturnal reflux complaints to sleep more on their lef

patient will only receive sleep advice (sleep on your left side). The sham group will only vibrate in the first 30 minutes of the night.

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 3 times a week during the night. -A total reflux symptom score =8 (measured through the GERDQ questionnaire score).

Exclusion criteria

Exclusion criteria: -Nightshift workers -Surgery of the esophagus or stomach. -Regular use of sleep medication (benzodiazepines) that cannot be stopped during the duration of the trial. -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 with obstructive sleep apnea.

Design outcomes

Primary

Measure	Time frame
Treatment success, defined as a 50% reduction in Nocturnal GERD Symptom Severity score from baseline (N-GSSIQ questionnaire).	—

Secondary

Measure	Time frame
-Nocturnal reflux free nights (measured by symptom diary on daily basis – one question) -Change in reflux symptoms (measured by RDQ & symptom diary) -Change in nocturnal reflux symptoms (measured by N-GSSIQ questionnaire and symptom diary) -Change in work productivity (measured by WPAI-GERD questionnaire). -Change in sleep position during study (supine, prone, left lateral decubitus or right lateral decubitus). -Change in sleep quality (measured by the PSQI questionnaire) -Global assessment of treatment on nocturnal reflux symptoms (‘’ Compared to the start of the treatment, how would you rate your nocturnal reflux symptoms now?’’)	—

Measure

Time frame

-Nocturnal reflux free nights (measured by symptom diary on daily basis – one question) -Change in reflux symptoms (measured by RDQ & symptom diary) -Change in nocturnal reflux symptoms (measured by N-GSSIQ questionnaire and symptom diary) -Change in work productivity (measured by WPAI-GERD questionnaire). -Change in sleep position during study (supine, prone, left lateral decubitus or right lateral decubitus). -Change in sleep quality (measured by the PSQI questionnaire) -Global assessment of treatment on nocturnal reflux symptoms (‘’ Compared to the start of the treatment, how would you rate your nocturnal reflux symptoms now?’’)

—

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)