Pediatric Sleep Questionnaire: Normalization and Validation Study

Sleep Disorders Clinical Trial

Official title:

Pediatric Sleep Questionnaire: Normalization and Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203840
• Other study ID #: 13270A
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 12, 2016
• Start date: August 2004
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The information gathered from normal pediatric patients seen at the Pediatric Neurology Clinic in the DCAM and LaRabida Children's Hospital will be used to standardize and validate the information gathered from pediatric patients with sleep disorders. This will serve as the information source for a pediatric sleep database.

Description:

A sleep questionnaire will be administered to patients who present to the Pediatric Neurology Clinic and LaRabida Children's Hospital. The questions asked are those routinely obtained in the clinical practice of sleep medicine. Medical students, residents and faculty as part of their normal clinical responsibilities will administer the questionnaire. The database will be maintained in Filemaker Pro program for future research purposes. Collection of the data will require approximately 15 minutes. A database file number not related to the patient medical record number will be assigned to each patient. The investigator will keep a separate log linking patient database number and patient medical record number. The logbook will be kept under lock and key by the investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• All patients seen in the Pediatric Neurology Clinic and at LaRabida Children's Hospital

Exclusion Criteria:

• Adults

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorders

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Sleep Questionnaire	This questionnaire is used to better understand the natural history of sleeping disorders in children.	When data from clinic patients becomes available	No