Differential Effects of Zolpidem Versus Ramelteon in Burned Children (Sleep3)

June 26, 2016 updated by: Michele Gottschlich, Shriners Hospitals for Children

Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings

To examine sleep changes following therapeutic drug interventions designed to promote sleep.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

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

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Shriners Hospital for Children

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

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Burn injury > 20% total body surface area
  • Between 3 and 18 years of age
  • < 7 days from acute injury
  • Written informed consent and HIPPA release signed

Exclusion Criteria:

  • Suspected anoxic brain injury or head injury
  • Hepatic or endocrine disease
  • History of alcoholism or substance abuse
  • Pre-existing neurological or primary psychiatric disorder
  • Medical history of pre-existing sleep disorder or lactose deficiency
  • Questionable survival (<72 hrs) as decided by PI
  • Receipt of drugs with known effects on sleep within 24 hrs of study entry
  • No informed consent/HIPPA release

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: zolpidem
zolpidem or ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
zolpidem dosed at 2200 and 0200 per feeding tube depending on randomization
Other Names:
  • Ambien
ACTIVE_COMPARATOR: ramelteon
ramelteon or zolpidem dosed at 2200 and 0200 per the feeding tube depending on randomization
ramelteon dosed at 2200 and 0200 per feeding tube depending on randomization
Other Names:
  • rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnography Data
Time Frame: 2 weeks postburn
Determine if intervention product elicits more total sleep time
2 weeks postburn

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics
Time Frame: 2 weeks postburn
evaluate the PK of zolpidem following standard dosing practices
2 weeks postburn

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Michele M Gottschlich, PhD, Shriners Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

December 1, 2009

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

October 2, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (ESTIMATE)

October 4, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 27, 2016

Last Update Submitted That Met QC Criteria

June 26, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 09-04-07-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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