Sensory Integration (Processing) Disorder Among Children With Behavioral Insomnia and Children With Feeding Disorder

January 15, 2014 updated by: Tel-Aviv Sourasky Medical Center

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

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

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

      • Tel-Aviv, Israel
        • Recruiting
        • Pediatric Sleep Center at Dana Children's hospital

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

7 months to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

Group / Cohort
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
Control
7-36 months old chidren of age who attend well-care clinics in the metropolitan of Tel Aviv for routine periodic medical examination.
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.

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.
Imidietly after the questionnaire filled by the parent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

August 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • TASMC-11-RT-0471-11-CTIL

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.

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