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NCT01729715 Clinical Trial

Helping Young Children Sleep

Insomnia Clinical Trial

Official title:
Helping Young Children Sleep

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01729715
Other study ID # IRB12-00439
Secondary ID
Status Completed
Phase N/A
First received November 15, 2012
Last updated July 19, 2017
Start date November 2012
Est. completion date March 2017

Study information
Verified date July 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date March 2017
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 36 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Internet

• DVD

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brief infant sleep questionnaire infant sleep patterns and sleep problems 3 weeks
Secondary Profile of mood states parental mood in the past week 1 week
Secondary Pittsburgh sleep quality index parental sleep patterns within the past month 1 month
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