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

NCT ID: NCT02040688

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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SID Feeding Disorder SPD

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Control

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

7 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric Sleep Center at Dana Children's hospital

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Riva Tauman, Dr.

Role: CONTACT

Facility Contacts

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Riva Tauman, Dr.

Role: primary

Other Identifiers

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TASMC-11-RT-0471-11-CTIL

Identifier Type: -

Identifier Source: org_study_id

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