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Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04309786
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Wake Forest University
Information provided by (Responsible Party):
Seema Aceves, University of California, San Diego

Brief Summary:
Eosinophilic esophagitis

Condition or disease
Eosinophilic Esophagitis

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).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Somatization, Anxiety and Sleep Disorders in Pediatric Patients With Eosinophilic Esophagitis
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : April 11, 2021
Estimated Study Completion Date : April 11, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Somatization [ 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.

  2. Sleep Quality [ Time Frame: Up to One month or in general ]
    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

  3. Anxiety [ Time Frame: At the moment and usually ]
    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.

  4. Reslilience [ Time Frame: One Month ]
    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.

  5. Symptoms [ Time Frame: One month ]
    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.

  6. Quality of Life [ Time Frame: One Month ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04309786

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Contact: Emad Khosh hemmat, BS 8589661700 ext 226884
Contact: Seema Aceves, MD, PhD 8585342983

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United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Emad K Khosh hemmat, BS    858-966-1700 ext 226884   
Contact: Seema Aceves, MD,PhD    8585432983   
Sponsors and Collaborators
University of California, San Diego
Wake Forest University
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Responsible Party: Seema Aceves, Professor, Pediatrics and Medicine, University of California, San Diego Identifier: NCT04309786    
Other Study ID Numbers: 190374
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seema Aceves, University of California, San Diego:
Additional relevant MeSH terms:
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Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Immune System Diseases