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Clinical Trials/NCT01729715
NCT01729715
Completed
Not Applicable

Helping Young Children Sleep

Nationwide Children's Hospital1 site in 1 country240 target enrollmentNovember 2012
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ConditionsInsomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insomnia
Sponsor
Nationwide Children's Hospital
Enrollment
240
Locations
1
Primary Endpoint
Brief infant sleep questionnaire
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
March 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark Splaingard

Prof. and Dir. of pediatric sleep medicine

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • •6-36 months
  • •difficulties falling asleep or staying asleep
  • •DVD and internet access

Exclusion Criteria

  • •Under 14 pounds
  • •Requires nighttime feeding or parental intervention for health reasons
  • •Chronic medical or psychological conditions such as asthma or autism
  • •Parents prefer co-sleeping

Outcomes

Primary Outcomes

Brief infant sleep questionnaire

Time Frame: 3 weeks

infant sleep patterns and sleep problems

Secondary Outcomes

  • Profile of mood states(1 week)
  • Pittsburgh sleep quality index(1 month)

Study Sites (1)

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