Clinical trial NCT06075082: The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Official title: The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Heartburn
Keywords: Sleep positional therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objectives of the study are (1) to investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gastroesophageal reflux disease symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Detailed description: Gastroesophageal reflux disease (GERD) is one of the most common gastro-intestinal disorders and approximately 50-80% of the GERD patients experience nocturnal gastroesophageal reflux symptoms. Symptoms at night have a negative impact on sleep quality, daytime functioning and quality of life. When sleeping in left lateral decubitus position, the stomach is positioned below the esophagus, resulting in less reflux compared to sleeping in right lateral decubitus position. Sleep positional therapy, using an electronic wearable device which gently vibrates in an annoying way when turning in the sleep to the disadvantageous right lateral decubitus position, stimulates subjects to avoid sleeping in the right lateral decubitus position and effectively alleviates nocturnal gastroesophageal reflux symptoms. This prospective single center interventional pilot study will aim to (1) investigate if sleep positional therapy, using the LEFT smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with GERD symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Both male and female patients will be included.
* Age 18 years or older.
* Symptoms of heartburn and/or acid regurgitation during at least three nights a week.
* A total reflux symptom score ≥8 (measured through the GERDQ questionnaire score).
* Able to wear the Apple Watch on the left wrist.

Exclusion Criteria:

* Complete PPIs non-responders.
* Nightshift workers
* Surgery of the esophagus or stomach.
* Regular use of sleep medication (benzodiazepines) or medication which affect gastrointestinal motility (e.g. prokinetics or opioids) 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 or esophageal motility disorders.
* Pregnant or lactating women.

Primary outcomes:
measure: Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
timeFrame: 2 weeks
Secondary outcomes:
measure: Treatment success
timeFrame: 2 weeks
measure: Change in total Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score.
timeFrame: 2 weeks
measure: Sleep position
timeFrame: 2 weeks
measure: Number of nocturnal reflux free nights
timeFrame: 2 weeks
measure: Reflux disease questionnaire (RDQ)
timeFrame: 2 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks
measure: Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
References: