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

Feeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02040688
• Other study ID #: TASMC-11-RT-0471-11-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 9, 2014
• Last updated: January 15, 2014
• Start date: August 2011

Study information

• Verified date: January 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Riva Tauman, Dr.
• Email: tauman[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Months to 36 Months

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Feeding Disorder
• SID
• SPD

Locations

Country	Name	City	State
Israel	Pediatric Sleep Center at Dana Children's hospital	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of sleep disorders using Brief Infant Sleep Questionnaire (BISQ) and feeding disorders using the Behavioral Pediatrics Feeding Assessment.		Imidietly after the questionnaire filled by the parent.	No