- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309786
Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis
October 19, 2022 updated by: Seema Aceves, University of California, San Diego
A Pilot Study of Somatization, Anxiety and Sleep Disorders in Pediatric Patients With Eosinophilic Esophagitis
Eosinophilic esophagitis
Study Overview
Status
Completed
Conditions
Detailed Description
In order to decrease disease burden and the perception of disease burden, investigators need to understand the symptoms and severity of anxiety, disordered sleep, and somatization and how these parameters align with symptoms and quality of life in pediatric EoE.
To assess the burden of these parameters in children with EoE, investigators will conduct a single center pilot study of 60 children with EoE using validated indexes for anxiety (state trait anxiety inventory for children), somatization (children's somatization inventory), sleep (pediatric sleep questionnaire), coping (Connor-Davidson Resilience Score) symptoms (PEESSv2.0),
and quality of life (PedsQL-EoE).
Study Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Rady Children's Hospital San Diego
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children 8-18 years old seen in the Rady Children's EoE clinic population as part of routine care (n=60) patients
Description
Inclusion Criteria:
- Age 8-18 years old
- Ability to understand and complete the surveys and complete them in English
- Known diagnosis of EoE defined as > 15 eosinophils per high power field. Patient can have active or inactive disease at the time of entry
Exclusion Criteria:
- <8 or > 18 years old
- Inability to read the surveys in English
- Concurrent gastrointestinal diseases such as inflammatory bowel disease or Celiac disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Somatization score
Time Frame: Two weeks
|
Our researchers will be using CSSI-Child Somatic Symptoms Inventory to measure the severity of bothersome somatic symptoms experienced in our EoE children and adolescents.
Respondents are asked to rate the extent to which the child was bothered by each of the nonspecific somatic symptoms listed.
Total scores are computed by summing the ratings for each item.
Higher scores indicate greater somatic distress.
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Two weeks
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Sleep Quality score
Time Frame: Up to One month or in general
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Our researchers will be using PSQ-Pediatric Sleep Questionnaire to evaluate our EoE children's sleep disorder symptoms.
This multi-page questionnaire consists of closed question-items and several open questions.
The items are each answered yes = 1, no = 0, or don't know = missing.
The number of symptom-items endorsed positively ("yes") is divided by the number of items answered positively or negatively; the denominator therefore excludes items with missing responses and items answered as don't know.
The result is a number, a proportion that ranges from 0.0 to 1.0.
Scores > 0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder
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Up to One month or in general
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Anxiety score
Time Frame: At the moment and usually
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Our researchers will be using STAIC-State Trait Anxiety Questionnaire to evaluate.
Our EoE children will be answering the questions in two different forms in which they report how they feel at a particular moment in time when they respond to the S-Anxiety scale (C-1), and how they generally feel when they respond to the T-Anxiety scale (C-2).
Children respond to the STAIC by selecting one of the three alternative choices for each item which describes them best.
In essence, each STAIC item is a 3-point rating scale for which values of 1, 2, or 3 are assigned for each of the three alternative choices.
Thus, scores on both the STAIC S-Anxiety and T-Anxiety sub-scales can range from a minimum of 20 to a maximum score of 60.
Higher scores mean higher anxiety.
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At the moment and usually
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Resilience score
Time Frame: One Month
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Connor-Davidson Resilience Scale (CD-RISC), We will be using this uni-dimensional self-reported scale to measure resilience in our EoE patients.
Subjects will be responding to 10 items on a 5-point likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time).
Each item has a minimum score of 0 and a maximum score of 4. The total scores for this questionnaire range from a minimum of 0 to maximum of 40.
The total scores are calculated by summing all 10 items.
A higher score indicates higher resilience.
None of the items are reverse scored.
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One Month
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Symptoms score
Time Frame: One month
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Our researchers will be using the Pediatric Eosinophilic Esophagitis Symptom Score (PEESSv2.0)
to measure the severity and frequency of patient-relevant symptoms such as dysphagia, gastrointestinal reflux disease (GERD), nausea/vomiting, and pain.
The PEESsv2.0 is a content-validated metric that seeks to capture EoE-specific symptoms directly from children with EoE (8-18 years of age) and from their parents (2-18 years of age).
From parent/participant answers, four domains are evaluated: dysphagia, gastroesophageal reflux disease (GERD), nausea/vomiting and pain.
The range for these PEESS® v2.0 scores are 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms for total score, and the dysphagia, GERD, nausea/vomiting and pain domains.
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One month
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Quality of Life score
Time Frame: One Month
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Our researchers will be using PedsQL-EoE questionnaire to measure different dimensions of EoE such as symptoms, treatment, worry, communication, food and eating, and food feelings.
Children and parents answer 33 items comprising 7 dimensions mentioned above.
Items are 5-point Likert scale from 0(never) to 4 (Almost Always).
Scores are transformed on a scale from 0 to 100.
Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0.
The mean score = Sum of the items over the number of items answered.
Symptoms Total Scale Score can be obtained by Sum of the items over the number of items answered in the Symptoms I and Symptoms II Scales.
The total Score can be obtained by sum of all the items over the number of items answered on all the Scales except Feeding Tube Scale.
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One Month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 11, 2019
Primary Completion (ACTUAL)
April 26, 2021
Study Completion (ACTUAL)
April 26, 2021
Study Registration Dates
First Submitted
June 27, 2019
First Submitted That Met QC Criteria
March 13, 2020
First Posted (ACTUAL)
March 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 21, 2022
Last Update Submitted That Met QC Criteria
October 19, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190374
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Eosinophilic Esophagitis
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Children's Hospital Medical Center, CincinnatiNational Institute of Allergy and Infectious Diseases (NIAID); National Institute... and other collaboratorsCompletedEosinophilic Esophagitis (EoE) | Eosinophilic Gastrointestinal Disorders (EGIDs)United States
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Federico II UniversityRecruitingEsophagitis, EosinophilicItaly
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Ann & Robert H Lurie Children's Hospital of ChicagoRecruitingEosinophilic Gastroenteritis | Eosinophilic Esophagitis | Eosinophilic Colitis | Eosinophilic Gastrointestinal DiseaseUnited States
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Medical University of GrazRecruiting
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AQILION ABCompletedEosinophilic Esophagitis (EoE)United Kingdom
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Regeneron PharmaceuticalsSanofiActive, not recruitingEosinophilic Esophagitis (EoE)United States, Canada
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ShireTakeda Development Center Americas, Inc.TerminatedEosinophilic Esophagitis (EoE)United States
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ShireCompletedEosinophilic Esophagitis (EoE)United States
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ShireCompleted
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