Status:

COMPLETED

Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Lead Sponsor:

Stanford University

Conditions:

Sleep Disturbance

Trauma

Eligibility:

All Genders

18+ years

Phase:

NA

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 educat...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 7 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 24 2021

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT03779243

Start Date

January 7 2019

End Date

August 24 2021

Last Update

December 3 2021

Active Locations (1)

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Stanford

Stanford, California, United States, 94305