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Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

NCT03779243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-12-03

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Melatonin 5mg and Sleep Education

Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.

OTHER

Placebo

Daily placebo pills for 6 weeks following injury or surgery.

Sponsors & Collaborators

Principal Investigators

  • Michael J Gardner, MD · Stanford Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-08-24
Completion
2021-08-24

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779243 on ClinicalTrials.gov