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Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
Not Recruiting
Trial ID: NCT03779243
Purpose
The purpose of the study is to test the efficacy of sleep treatment in human patients following traumatic injury. Specifically, the study will determine if treatment consisting of melatonin and education related to sleep habits are effective in treating sleep disturbance and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and sleep education effectively improve sleep following traumatic injury, and improve outcomes.
Official Title
Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
Stanford Investigator(s)
Michael J. Gardner, MD
Hatim and Durriya Tyabji Endowed Professor
Eligibility
Inclusion Criteria:
* New patients visiting the Orthopaedic Trauma Clinic or undergoing orthopaedic surgery in Stanford Hospital following traumatic injury. Accidental traumatic fracture injuries that are operative and non-operative. Must be able to swallow tablets.
Exclusion Criteria:
* Documented head trauma. Cognitive impairments. Minors. Previously diagnosed sleep disorders. Sleep apnea. Enrolled in another study. Women who are pregnant or may become pregnant or are nursing. Hypertension. Diabetes. Endocrine, autoimmune, depressive, bleeding or seizure disorders.
Intervention(s):
other: Placebo
dietary_supplement: Melatonin 5mg and Sleep Education
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michael J Gardner, MD
650-498-9230