Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Disturbance
- Sponsor
- Stanford University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Mean Change in Pittsburgh Sleep Quality Index Score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Michael J. Gardner
PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER
Stanford University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Mean Change in Pittsburgh Sleep Quality Index Score
Time Frame: Baseline, week 6, and week 12
9-item self-rated questionnaire that assesses clinical sleep quality and disturbances. Global PSQI scores are sums of the component scores, and range from 0-21. Higher scores indicate worse sleep quality.
Secondary Outcomes
- 36-Item Short Form Survey (SF-36) to measure quality of life(Baseline, week 6, and week 12)
- Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)(Baseline, week 6, and week 12)