View Clinical Trial (Medical Research Study)
Differential Effects of Zolpidem Versus Ramelteon on Nocturnal Sleep in Pediatric Burn Patients: A Prospective, Randomized Crossover Trial With Polysomnographic Recordings
| City: |
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Cincinnati |
| State: |
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Ohio |
| Zip Code: |
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45229 |
| Conditions: |
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Sleep - Burns |
| Purpose: |
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To examine sleep changes following therapeutic drug interventions designed to promote sleep.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00539110 |
| Primary Contact: |
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Principal Investigator
Michele M Gottschlich
Shriners Hospital for Children
Michele M Gottschlich, PhD, RD, CNSD
Phone: 513-872-6298
Email: mgottschlich@shrinenet.org
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| Backup Contact: |
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Email: tmayes@shrinenet.org
Theresa Mayes, BS, RD
Phone: 513-872-6043
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| Location Contact: |
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Cincinnati, Ohio 45229
United States
Michele M Gottschlich, PhD, RD, CNSD
Phone: 513-872-6298
Email: mgottschlich@shrinenet.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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