Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Disturbance, Trauma

In brief

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.

Key facts

Study ID

NCT03779243

Run by

Stanford University

People needed

90

Starts

2019-01-07

Expected to finish

2021-08-24

Last updated by the study team

2021-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford — Stanford, California, United States

Full record on ClinicalTrials.gov

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