Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02706938
• Date of registration: 08/03/2016
• Prospective Registration: Yes
• Primary sponsor: Universidad Nacional de Colombia
• Public title: Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease IBELGA
• Scientific title: Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease: a Randomized Single-blind Study
• Date of first enrolment: April 8, 2016
• Target sample size: 65
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02706938
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: William A Otero Regino, MD, MSc
• Affiliation: Universidad Nacional de Colombia, Clínica Fundadores

• Name: Ivan M Villamil Morales, MD
• Affiliation: Universidad Nacional de Colombia

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastroesophageal Reflux Disease

Intervention(s)

Other: Standard treatment

Other: Head of bed elevation

Primary Outcome(s)

Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention [Time Frame: Primary outcome will be assessed at baseline and 6 weeks after starting each period]

Secondary Outcome(s)

Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention [Time Frame: Secondary outcome will be assessed at baseline and 6 weeks after starting each period]

Patient Preference [Time Frame: Secondary outcome will be assessed 14 weeks after starting the trial]

Secondary ID(s)

IBELGA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02706938