Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Trial ID or NCT#

NCT03779243

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Michael J. Gardner, MD
Michael J. Gardner, MD
Orthopaedic surgeon, Orthopaedic trauma surgeon
Professor of Orthopaedic Surgery

Contact us to find out if this trial is right for you.

Contact

Michael J Gardner, MD
650-498-9230