Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03779243
Other study ID # IRB-48700
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date August 24, 2021

Study information

Verified date December 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date August 24, 2021
Est. primary completion date August 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Stanford Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Swann MC, Batty M, Hu G, Mitchell T, Box H, Starr A. Sleep Disturbance in Orthopaedic Trauma Patients. J Orthop Trauma. 2018 Oct;32(10):500-504. doi: 10.1097/BOT.0000000000001276. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Pittsburgh Sleep Quality Index Score 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. Baseline, week 6, and week 12
Secondary 36-Item Short Form Survey (SF-36) to measure quality of life 36-item, patient-reported survey of patient health-related quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. Baseline, week 6, and week 12
Secondary Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS) VAS is scored on a continuum from 0-10 indicating "no pain" to "unbearable pain". Higher scores indicate more pain intensity. Baseline, week 6, and week 12
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Terminated NCT03781817 - Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures Phase 4
Completed NCT04342416 - Using a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women N/A
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT05669313 - The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With ROTEM
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Recruiting NCT04725721 - Testing FIRST in Youth Outpatient Psychotherapy N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT03696563 - FreeO2 PreHospital - Automated Oxygen Titration vs Manual Titration According to the BLS-PCS N/A
Withdrawn NCT03249129 - Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Completed NCT02240732 - Surgical Tourniquets and Cerebral Emboli N/A
Completed NCT02227979 - Effects of PURPLE Cry Intervention N/A
Withdrawn NCT01169025 - Fentanyl vs. Low-Dose Ketamine for the Relief of Moderate to Severe Pain in Aeromedical Patients N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT03112304 - Child STEPS for Youth Mental Health in Maine Sustainability N/A
Completed NCT01475344 - Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC) Phase 1/Phase 2
Completed NCT01201863 - Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy Phase 4
Completed NCT01210417 - Trauma Heart to Arm Time N/A