- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02040688
Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder
Behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. If left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family.
Feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders.
We have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders.
We hypotesize that SPD is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of Sensory intergration disorder (SID) compared with healthy controls.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Tel-Aviv, Israel
- Recruiting
- Pediatric Sleep Center at Dana Children's hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
7-36 months old children will be selected from:
- The clinic of feeding disorders at Dana Children's Hospital.
- The Pediatric Sleep Center at Dana Children's hospital
- Well-care clinics in the metropolitan of Tel Aviv
Description
Inclusion Criteria:
- children 7-36 months of age with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria .
- children 7-36 months of age with feeding disorders based on Chatoor criteria.
- children 7-36 months of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.
Exclusion Criteria:
Children with
- Chronic medical conditions.
- Congenital abnormalities.
- Significant developmental delay.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Sleep Disorders
7-36 months old children with behavioral insomnia of childhood based on the International Classification of Sleep Disorders (ICSD) criteria will be recruited from the Pediatric Sleep Center at Dana Children's hospital
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Control
7-36 months old chidren of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.
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Feeding disorder
7-36 monthsold children with feeding disorders based on Chatoor criteria will be recruited from the clinic of feeding disorders at Dana Children's Hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.
Time Frame: Imidietly after the questionnaire filled by the parent.
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Imidietly after the questionnaire filled by the parent.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-11-RT-0471-11-CTIL
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