Status:
COMPLETED
Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease
Lead Sponsor:
Universidad Nacional de Colombia
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and absenteeism. Head of bed elev...
Detailed Description
PROBLEM STATEMENT Gastroesophageal reflux disease (GERD) is a clinical condition characterized by troublesome symptoms and medical complications as a result of reflux of gastric contents into the eso...
Eligibility Criteria
Inclusion
- Esophageal erosions
- Retrosternal pyrosis lasting ≥ 3 months
- Pyrosis and/or regurgitation with a frequency ≥ 3 nights per week
- GERD-associated sleep disturbance (insomnia, poor sleep quality) lasting ≥ 1 month
- GERD-associated sleep disturbance (insomnia, poor sleep quality) with a frequency ≥ 3 nights per week
Exclusion
- Non-erosive gastroesophageal reflux disease (NERD)
- Peptic ulcer
- History of upper gastrointestinal surgery (except for cholecystectomy)
- Lactating or pregnant women
- Nighttime shift workers (12 am to 6 am)
- Obstructive sleep apnea hypopnea syndrome
- Chronic obstructive pulmonary disease
- Patients with nocturnal supplementary oxygen requirement
- Orthopnea
- Restless legs syndrome
- Patients consuming more than 3 cups of coffee per day
- Patients planning to travel beyond 3 time zones during study
- Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines) for less than 3 months
- Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines), when suspension or dose modification of this drugs is being planned during the study course
Key Trial Info
Start Date :
April 8 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02706938
Start Date
April 8 2016
End Date
November 15 2017
Last Update
June 24 2019
Active Locations (1)
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1
Clínica Fundadores
Bogotá, Cundinamarca, Colombia