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The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms. (LEFT-APP)

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ClinicalTrials.gov Identifier: NCT06075082
Recruitment Status : Recruiting
First Posted : October 10, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Prof.dr. A.J. (Arjan) Bredenoord, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Heartburn Device: LEFT smartwatch app Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sleep positional therapy by using the LEFT smartwatch app Device: LEFT smartwatch app
The LEFT smartwatch app is an app on the Apple Watch which measures body sleep position and gently vibrates when the body is in the right lateral decubitus position. In this way, patients with nocturnal gastroesophageal reflux symptoms learn to avoid the right lateral sleep position as they will avoid the annoying vibrations. Measurements while using the smartwatch app will be compared to measurements at baseline.


Outcome Measures
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Primary Outcome Measures :
  1. Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) [ Time Frame: 2 weeks ]

    The primary efficacy measure is relative change in total nocturnal gastroesophageal reflux symptoms measured by the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ).

    The N-GSSIQ is a 20-item questionnaire measuring the severity, morning impact and concern about nocturnal gastro-esophageal reflux disease. The N-GSSIQ is a validated questionnaire to assess nocturnal GERD symptom severity over the past 2 weeks. The N-GSSIQ is comprised of three subscales: Nocturnal Gastroesophageal Reflux Disease Symptom Severity (13 questions, score range 0-65), Morning Impact of Nocturnal Gastroesophageal Reflux Disease (2 questions, score range 0-10), and Concern about Nocturnal Gastroesophageal Reflux Disease (5 questions, score range 0-20). Total score ranging from 0 to 95. A higher score indicates more severe symptoms.



Secondary Outcome Measures :
  1. Treatment success [ Time Frame: 2 weeks ]
    Percent responders as treatment success, defined as subjects with a minimal 50% reduction in nocturnal gastroesophageal reflux symptoms measured by N-GSSIQ

  2. Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) [ Time Frame: 2 weeks ]

    Change in total Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ) score.

    The N-GSSIQ is a 20-item questionnaire measuring the severity, morning impact and concern about nocturnal gastro-esophageal reflux disease. The N-GSSIQ is a validated questionnaire to assess nocturnal GERD symptom severity over the past 2 weeks. The N-GSSIQ is comprised of three subscales: Nocturnal Gastroesophageal Reflux Disease Symptom Severity (13 questions, score range 0-65), Morning Impact of Nocturnal Gastroesophageal Reflux Disease (2 questions, score range 0-10), and Concern about Nocturnal Gastroesophageal Reflux Disease (5 questions, score range 0-20). Total score ranging from 0 to 95. A higher score indicates more severe symptoms.


  3. Sleep position [ Time Frame: 2 weeks ]
    Change in sleep position. Four sleep positions will be studied: left lateral decubitus, right lateral decubitus, supine and prone. The outcome sleep position will be noted as percentage of the time sleeping in a certain sleep position during the entire sleep.

  4. Number of nocturnal reflux free nights [ Time Frame: 2 weeks ]
    Change in the number of nocturnal reflux free nights measured by daily symptom diary

  5. Reflux disease questionnaire (RDQ) [ Time Frame: 2 weeks ]

    Change in reflux symptoms measured by Reflux disease questionnaire (RDQ) questionnaire.

    The RDQ is a validated 12-item questionnaire to obtain information on the current severity and frequency of reflux symptoms (heartburn, regurgitation and dyspepsia). The three subscales are the different reflux symptoms and consist of four questions. Scores were scaled with a Likert scale which ranges from 0 to 5. Subjects have more frequent and severe reflux symptoms if the RDQ score is higher


  6. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 weeks ]

    Change in sleep quality measured by Pittsburgh Sleep Quality Index (PSQI).

    The PSQI is a validated 19-item questionnaire assessing various factors relating to sleep quality, sleep disturbance and usual sleep habits. The 19 items are grouped into seven component scores (sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction). The seven component scores are summed to calculate a global PSQI score, which has a range of 0-21. A higher score indicates a worse sleep quality; and a score above 5 is suspect for insomnia.


  7. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 2 weeks ]

    Change in sleep quality measured by Functional Outcomes of Sleep Questionnaire (FOSQ).

    The FOSQ is a validated questionnaire about sleep-quality of life which consists of 30 questions. The short form which consists of 10 questions will be used in this study. Questions have a 4-point Likert scale. The recall period is not specified, but two weeks will be used in this study. A lowerscore indicates a worse sleep quality.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06075082


Contacts
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Contact: Elise M Wessels, dr. +31205667805 e.wessels@amsterdamumc.nl
Contact: Arjan J Bredenoord, prof. dr. +31650091323 a.j.bredenoord@amsterdamumc.nl

Locations
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Netherlands
Amsterdam UMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Elise M Wessels, dr.    +31205667805    e.wessels@amsterdamumc.nl   
Contact: Arjan J Bredenoord, prof. dr.    +31650091323    a.j.bredenoord@amsterdamumc.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information
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Responsible Party: Prof.dr. A.J. (Arjan) Bredenoord, Prof. dr. A.J. Bredenoord, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT06075082    
Other Study ID Numbers: NL83321.018.22
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof.dr. A.J. (Arjan) Bredenoord, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Sleep positional therapy
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Signs and Symptoms, Digestive