Trial Outcomes & Findings for Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease (NCT NCT02706938)
NCT ID: NCT02706938
Last Updated: 2019-06-24
Results Overview
Change in Reflux Disease Questionnaire Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 6, with a higher punctuation meaning a worse outcome. Symptom change of ≥ 0,6 points from baseline was considered clinically relevant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Primary outcome will be assessed at baseline and 6 weeks after starting each period
Results posted on
2019-06-24
Participant Flow
This trial was conducted at the outpatient visit of the Gastroenterology, Digestive endoscopy and Liver Diseases Unit in Clínica Fundadores, Bogotá, Colombia. A search for eligible patients was also conducted by using a Local Endoscopy Database with a time frame from 2014 to 2016, and patients with esophagitis were contacted by telephone.
1082 out of 1147 potentially eligible patients were excluded prior to randomization. 941 patients did not meet the inclusion criteria and 105 patients had at least one exclusion criteria. 36 patients declined their participation before starting the clinical trial.
Participant milestones
| Measure |
Head of Bed Elevation - Control
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control - Head of Bed Elevation
Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
First Period, 6 Weeks
STARTED
|
32
|
33
|
|
First Period, 6 Weeks
COMPLETED
|
21
|
31
|
|
First Period, 6 Weeks
NOT COMPLETED
|
11
|
2
|
|
Second Period, 6 Weeks
STARTED
|
21
|
31
|
|
Second Period, 6 Weeks
COMPLETED
|
21
|
21
|
|
Second Period, 6 Weeks
NOT COMPLETED
|
0
|
10
|
Reasons for withdrawal
| Measure |
Head of Bed Elevation - Control
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control - Head of Bed Elevation
Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
First Period, 6 Weeks
Adverse Event
|
8
|
0
|
|
First Period, 6 Weeks
Lost to Follow-up
|
2
|
2
|
|
First Period, 6 Weeks
Withdrawal by Subject
|
1
|
0
|
|
Second Period, 6 Weeks
Adverse Event
|
0
|
7
|
|
Second Period, 6 Weeks
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Row population differs from the Overall because of missing data
Baseline characteristics by cohort
| Measure |
Head of Bed Elevation - Control
n=32 Participants
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control - Head of Bed Elevation
n=33 Participants
Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 year
STANDARD_DEVIATION 8.0 • n=32 Participants
|
54 year
STANDARD_DEVIATION 12.6 • n=33 Participants
|
55.5 year
STANDARD_DEVIATION 10.6 • n=65 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=32 Participants
|
30 Participants
n=33 Participants
|
53 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
12 Participants
n=65 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=32 Participants
|
32 Participants
n=33 Participants
|
64 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Los Angeles Classification
Grade A Esophagitis
|
23 Participants
n=32 Participants
|
30 Participants
n=33 Participants
|
53 Participants
n=65 Participants
|
|
Los Angeles Classification
Grade B Esophagitis
|
8 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
11 Participants
n=65 Participants
|
|
Los Angeles Classification
Grade C Esophagitis
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=65 Participants
|
|
Los Angeles Classification
Grade D Esophagitis
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=65 Participants
|
|
GERD diagnosis
|
5 Years
n=32 Participants
|
5 Years
n=33 Participants
|
5 Years
n=65 Participants
|
|
GERD-associated sleep disturbance
|
3.5 Nights per week
n=32 Participants
|
4 Nights per week
n=33 Participants
|
4 Nights per week
n=65 Participants
|
|
Proton pump inhibitor use
|
25 Participants
n=32 Participants
|
31 Participants
n=33 Participants
|
56 Participants
n=65 Participants
|
|
Omeprazole use
|
4 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Esomeprazole use
|
15 Participants
n=32 Participants
|
22 Participants
n=33 Participants
|
37 Participants
n=65 Participants
|
|
Lansoprazole use
|
6 Participants
n=32 Participants
|
3 Participants
n=33 Participants
|
9 Participants
n=65 Participants
|
|
Sodium Alginate use
|
7 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
13 Participants
n=65 Participants
|
|
GERD therapy adherence
|
14 Participants
n=26 Participants • Row population differs from the Overall because of missing data
|
18 Participants
n=30 Participants • Row population differs from the Overall because of missing data
|
32 Participants
n=56 Participants • Row population differs from the Overall because of missing data
|
|
OTC antacid use
|
4 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Number of pillows
|
2 pillows
n=32 Participants
|
2 pillows
n=33 Participants
|
2 pillows
n=65 Participants
|
|
Sleep medication
|
5 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Nocturia
|
3.5 Nights per week
n=32 Participants
|
6 Nights per week
n=33 Participants
|
4 Nights per week
n=65 Participants
|
|
Cups of coffee
|
1 cup
n=32 Participants
|
1 cup
n=33 Participants
|
1 cup
n=65 Participants
|
|
Weight
|
67.5 Kilogram
STANDARD_DEVIATION 12.7 • n=31 Participants • This row populattion differs from the overall because of missed data
|
61.8 Kilogram
STANDARD_DEVIATION 9.5 • n=33 Participants • This row populattion differs from the overall because of missed data
|
64.6 Kilogram
STANDARD_DEVIATION 11.4 • n=64 Participants • This row populattion differs from the overall because of missed data
|
|
Height
|
161.4 centimeter
STANDARD_DEVIATION 9.6 • n=31 Participants • This row populattion differs from the overall because of missed data
|
159.4 centimeter
STANDARD_DEVIATION 5.7 • n=33 Participants • This row populattion differs from the overall because of missed data
|
160.4 centimeter
STANDARD_DEVIATION 7.8 • n=64 Participants • This row populattion differs from the overall because of missed data
|
|
Body Mass Index
|
24.5 Kilogram/square meter
n=31 Participants • This row populattion differs from the overall because of missed data
|
24.9 Kilogram/square meter
n=33 Participants • This row populattion differs from the overall because of missed data
|
24.6 Kilogram/square meter
n=64 Participants • This row populattion differs from the overall because of missed data
|
|
Basal RDQ score
|
3.8 Score on a scale
STANDARD_DEVIATION 1.01 • n=31 Participants • This row populattion differs from the overall because of missed data
|
4 Score on a scale
STANDARD_DEVIATION 1.08 • n=32 Participants • This row populattion differs from the overall because of missed data
|
3.9 Score on a scale
STANDARD_DEVIATION 1.04 • n=63 Participants • This row populattion differs from the overall because of missed data
|
|
SF-36 score
|
54 scores on a scale
STANDARD_DEVIATION 19.9 • n=30 Participants • This row populattion differs from the overall because of missed data
|
48.8 scores on a scale
STANDARD_DEVIATION 21.4 • n=31 Participants • This row populattion differs from the overall because of missed data
|
51.3 scores on a scale
STANDARD_DEVIATION 20.7 • n=61 Participants • This row populattion differs from the overall because of missed data
|
|
SF-36 Physical Function domain
|
65 scores on a scale
n=30 Participants • This row populattion differs from the overall because of missed data
|
55 scores on a scale
n=31 Participants • This row populattion differs from the overall because of missed data
|
60 scores on a scale
n=61 Participants • This row populattion differs from the overall because of missed data
|
|
SF-36 Physical Role domain
|
49.2 scores on a scale
STANDARD_DEVIATION 45.7 • n=30 Participants • This row populattion differs from the overall because of missed data
|
32.2 scores on a scale
STANDARD_DEVIATION 42.4 • n=31 Participants • This row populattion differs from the overall because of missed data
|
40.6 scores on a scale
STANDARD_DEVIATION 44.5 • n=61 Participants • This row populattion differs from the overall because of missed data
|
|
SF-36 Bodily Pain domain
|
43.8 scores on a scale
STANDARD_DEVIATION 25 • n=30 Participants • This row populattion differs from the overall because of missed data
|
40.9 scores on a scale
STANDARD_DEVIATION 26.5 • n=31 Participants • This row populattion differs from the overall because of missed data
|
42.3 scores on a scale
STANDARD_DEVIATION 25.6 • n=61 Participants • This row populattion differs from the overall because of missed data
|
|
SF-36 General Health Domain
|
51.8 scores on a scale
STANDARD_DEVIATION 16.5 • n=30 Participants • Row population differs from the Overall because of missing data
|
49.5 scores on a scale
STANDARD_DEVIATION 18.2 • n=31 Participants • Row population differs from the Overall because of missing data
|
50.6 scores on a scale
STANDARD_DEVIATION 17.3 • n=61 Participants • Row population differs from the Overall because of missing data
|
|
SF-36 Vitality Domain
|
51 scores on a scale
STANDARD_DEVIATION 15.8 • n=30 Participants • Row population differs from the Overall because of missing data
|
45.5 scores on a scale
STANDARD_DEVIATION 20.7 • n=31 Participants • Row population differs from the Overall because of missing data
|
48.2 scores on a scale
STANDARD_DEVIATION 18.5 • n=61 Participants • Row population differs from the Overall because of missing data
|
|
SF-36 Social Function Domain
|
67.5 scores on a scale
n=30 Participants • Row population differs from the Overall because of missing data
|
67.5 scores on a scale
n=31 Participants • Row population differs from the Overall because of missing data
|
67.5 scores on a scale
n=61 Participants • Row population differs from the Overall because of missing data
|
|
SF-36 Emotional Role domain
|
60 scores on a scale
STANDARD_DEVIATION 44.1 • n=30 Participants • Row population differs from the Overall because of missing data
|
57 scores on a scale
STANDARD_DEVIATION 45.7 • n=31 Participants • Row population differs from the Overall because of missing data
|
58.5 scores on a scale
STANDARD_DEVIATION 44.6 • n=61 Participants • Row population differs from the Overall because of missing data
|
|
SF-36 Mental Health domain
|
60.8 scores on a scale
STANDARD_DEVIATION 18 • n=30 Participants • Row population differs from the Overall because of missing data
|
57.9 scores on a scale
STANDARD_DEVIATION 22.8 • n=31 Participants • Row population differs from the Overall because of missing data
|
59.3 scores on a scale
STANDARD_DEVIATION 20.5 • n=61 Participants • Row population differs from the Overall because of missing data
|
|
SF-36 Transition domain
|
45 scores on a scale
STANDARD_DEVIATION 19 • n=30 Participants • Row population differs from the Overall because of missing data
|
37.9 scores on a scale
STANDARD_DEVIATION 22.2 • n=31 Participants • Row population differs from the Overall because of missing data
|
41.4 scores on a scale
STANDARD_DEVIATION 20.8 • n=61 Participants • Row population differs from the Overall because of missing data
|
|
Comorbidities
|
1.5 Comorbidity
n=32 Participants
|
2 Comorbidity
n=33 Participants
|
2 Comorbidity
n=65 Participants
|
|
Arterial hypertension
|
6 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
11 Participants
n=65 Participants
|
|
Varicose veins
|
3 Participants
n=32 Participants
|
8 Participants
n=33 Participants
|
11 Participants
n=65 Participants
|
|
Hypothyroidism
|
4 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Fibromyalgia
|
5 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
10 Participants
n=65 Participants
|
|
Arthrosis
|
5 Participants
n=32 Participants
|
4 Participants
n=33 Participants
|
9 Participants
n=65 Participants
|
|
Irritable bowel syndrome
|
3 Participants
n=32 Participants
|
5 Participants
n=33 Participants
|
8 Participants
n=65 Participants
|
|
Depressive disorder
|
2 Participants
n=32 Participants
|
6 Participants
n=33 Participants
|
8 Participants
n=65 Participants
|
|
Obesity
|
6 Participants
n=31 Participants • Row population differs from the Overall because of missing data
|
2 Participants
n=33 Participants • Row population differs from the Overall because of missing data
|
8 Participants
n=64 Participants • Row population differs from the Overall because of missing data
|
|
Anxiety disorder
|
3 Participants
n=32 Participants
|
4 Participants
n=33 Participants
|
7 Participants
n=65 Participants
|
|
Spondylopathy
|
2 Participants
n=32 Participants
|
2 Participants
n=33 Participants
|
4 Participants
n=65 Participants
|
|
Type 2 Diabetes Mellitus
|
1 Participants
n=32 Participants
|
2 Participants
n=33 Participants
|
3 Participants
n=65 Participants
|
|
Other comorbidities
|
10 Participants
n=32 Participants
|
16 Participants
n=33 Participants
|
26 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: Primary outcome will be assessed at baseline and 6 weeks after starting each periodPopulation: All patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. Only 39 patients who completed both interventions were analyzed because of the crossover nature of this clinical trial.
Change in Reflux Disease Questionnaire Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 6, with a higher punctuation meaning a worse outcome. Symptom change of ≥ 0,6 points from baseline was considered clinically relevant.
Outcome measures
| Measure |
Head of Bed Elevation
n=39 Participants
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control
n=39 Participants
Participants will sleep in a bed without inclination during a first period of 6 weeks.
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention
|
-1.2397 scores on a scale
Standard Deviation 1.2236
|
0.0869 scores on a scale
Standard Deviation 1.2562
|
SECONDARY outcome
Timeframe: Secondary outcome will be assessed at baseline and 6 weeks after starting each periodPopulation: Patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. For crossover reasons, only 39 patients who completed both interventions were analyzed, and 1 patient was excluded because of missing data
Change in Short Form 36 Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 100, with a higher punctuation meaning a better outcome. Quality of life change of ≥ 10 points from baseline was considered clinically relevant.
Outcome measures
| Measure |
Head of Bed Elevation
n=38 Participants
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control
n=38 Participants
Participants will sleep in a bed without inclination during a first period of 6 weeks.
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention
|
6.5992 scores on a scale
Standard Deviation 19.0268
|
-0.3139 scores on a scale
Standard Deviation 17.6856
|
SECONDARY outcome
Timeframe: Secondary outcome will be assessed 14 weeks after starting the trialPopulation: All participants who used both head of bed elevation and control interventions, regardless they did not complete the entire trial or did not retrieve all the questionnaires, were asked for their preference between head of bed elevation or control intervention.
Percentage of patients who preferred head of bed elevation after trial ending
Outcome measures
| Measure |
Head of Bed Elevation
n=57 Participants
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control
Participants will sleep in a bed without inclination during a first period of 6 weeks.
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
Patient Preference
|
63.158 percent of participants
Interval 50.635 to 75.681
|
—
|
Adverse Events
Head of Bed Elevation
Serious events: 15 serious events
Other events: 24 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Head of Bed Elevation
n=63 participants at risk
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control
n=54 participants at risk
Participants will sleep in a bed without inclination during a first period of 6 weeks.
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
Vascular disorders
Varicose veins pain
|
6.3%
4/63 • Number of events 4 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Product Issues
Bed slipping
|
6.3%
4/63 • Number of events 4 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
3.2%
2/63 • Number of events 2 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Product Issues
Bed unsteadiness
|
4.8%
3/63 • Number of events 3 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
Other adverse events
| Measure |
Head of Bed Elevation
n=63 participants at risk
Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.
Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
Control
n=54 participants at risk
Participants will sleep in a bed without inclination during a first period of 6 weeks.
Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
|
|---|---|---|
|
Product Issues
Bed slipping
|
25.4%
16/63 • Number of events 16 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Vascular disorders
Varicose veins pain
|
9.5%
6/63 • Number of events 6 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Nervous system disorders
Headache
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Cervical pain
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Lumbar pain
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Product Issues
Bed unsteadiness
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
|
Reproductive system and breast disorders
Sexual activity interference
|
1.6%
1/63 • Number of events 1 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
0.00%
0/54 • Adverse event data were collected over a period of 14 weeks for each participant.
The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention. Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.
|
Additional Information
Dr. Ivan Mauricio Villamil Morales
Universidad Nacional de Colombia
Phone: +573178755369
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place