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

Primary Purpose

Gastroesophageal Reflux, Heartburn

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
LEFT smartwatch app
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Sleep positional therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam UMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep positional therapy by using the LEFT smartwatch app

Arm Description

Outcomes

Primary Outcome Measures

Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
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

Treatment success
Percent responders as treatment success, defined as subjects with a minimal 50% reduction in nocturnal gastroesophageal reflux symptoms measured by N-GSSIQ
Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
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.
Sleep position
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.
Number of nocturnal reflux free nights
Change in the number of nocturnal reflux free nights measured by daily symptom diary
Reflux disease questionnaire (RDQ)
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
Pittsburgh Sleep Quality Index (PSQI)
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.
Functional Outcomes of Sleep Questionnaire (FOSQ)
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.

Full Information

First Posted
September 27, 2023
Last Updated
October 3, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT06075082
Brief Title
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Acronym
LEFT-APP
Official Title
The Effect of the LEFT Smartwatch App as Sleep Positional Therapy for Nocturnal Gastroesophageal Reflux Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Heartburn
Keywords
Sleep positional therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep positional therapy by using the LEFT smartwatch app
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LEFT smartwatch app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Treatment success
Description
Percent responders as treatment success, defined as subjects with a minimal 50% reduction in nocturnal gastroesophageal reflux symptoms measured by N-GSSIQ
Time Frame
2 weeks
Title
Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ)
Description
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.
Time Frame
2 weeks
Title
Sleep position
Description
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.
Time Frame
2 weeks
Title
Number of nocturnal reflux free nights
Description
Change in the number of nocturnal reflux free nights measured by daily symptom diary
Time Frame
2 weeks
Title
Reflux disease questionnaire (RDQ)
Description
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
Time Frame
2 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
2 weeks
Title
Functional Outcomes of Sleep Questionnaire (FOSQ)
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise M Wessels, dr.
Phone
+31205667805
Email
e.wessels@amsterdamumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Arjan J Bredenoord, prof. dr.
Phone
+31650091323
Email
a.j.bredenoord@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise M Wessels, dr.
Phone
+31205667805
Email
e.wessels@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Arjan J Bredenoord, prof. dr.
Phone
+31650091323
Email
a.j.bredenoord@amsterdamumc.nl

12. IPD Sharing Statement

Learn more about this trial

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

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