Eosinophilic EsophagitisNCT04309786
Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by University of California, San Diego at 1 site in United States.
Trial summary
Eosinophilic esophagitis Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 26 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children 8-18 years old seen in the Rady Children's EoE clinic population as part of routine care (n=60) patients
Who may be able to join
- 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
Who cannot join
- <8 or > 18 years old
- Inability to read the surveys in English
- Concurrent gastrointestinal diseases such as inflammatory bowel disease or Celiac disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rady Children's Hospital San Diego
San Diego, California, 92123
About this study
Official title: A Pilot Study of Somatization, Anxiety and Sleep Disorders in Pediatric Patients With Eosinophilic Esophagitis
Eosinophilic esophagitis
Read the 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).
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EoE
- Medical subject headings
- Eosinophilic Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatization score
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.
Measured: Two weeks
Sleep Quality score
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
Measured: Up to One month or in general
Anxiety score
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.
Measured: At the moment and usually
Resilience score
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.
Measured: One Month
Symptoms score
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.
Measured: One month
Quality of Life score
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.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start11 Apr 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University
- Responsible party
- Principal investigator, Seema Aceves, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309786
- Sponsor's protocol ID
- 190374
- Status last verified
- Oct 2022
- First submitted
- 27 Jun 2019
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Somatization, Anxiety and Sleep Disorders in Pediatric Patients With Eosinophilic Esophagitis
- ClinicalTrials.gov ID
- NCT04309786
- Acronym / sponsor ID
- 190374
- Conditions
- Eosinophilic Esophagitis
- Keywords
- EoE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Wake Forest University
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children 8-18 years old seen in the Rady Children's EoE clinic population as part of routine care (n=60) patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- <8 or > 18 years old
- Inability to read the surveys in English
- Concurrent gastrointestinal diseases such as inflammatory bowel disease or Celiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Sleep Quality score
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
Anxiety score
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.
Resilience score
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.
Symptoms score
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.
Quality of Life score
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatization score (time frame: Two weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.