Pediatric Sleep Questionnaire: Normalization and Validation Study

May 12, 2016 updated by: University of Chicago

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.

Study Overview

Status

Completed

Conditions

Sleep Disorders

Detailed 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.

Study Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Chicago, Illinois, United States, 60637
    - The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with sleep disorders

Description

Inclusion Criteria:

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

Exclusion Criteria:

Adults

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Sleep Questionnaire Time Frame: When data from clinic patients becomes available	This questionnaire is used to better understand the natural history of sleeping disorders in children.	When data from clinic patients becomes available

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

Principal Investigator: Michael Kohrman, M.D., University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria