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OpenTrials
Completed

NCT Number: NCT03779243

Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

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.

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin 5mg and Sleep Education

Dietary Supplement

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

Placebo

Other

Daily placebo pills for 6 weeks following injury or surgery.

Primary outcomes

  1. 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

  1. 36-Item Short Form Survey (SF-36) to measure quality of life

    Time frame: Baseline, week 6, and week 12

    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.

  2. Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)

    Time frame: Baseline, week 6, and week 12

    VAS is scored on a continuum from 0-10 indicating "no pain" to "unbearable pain". Higher scores indicate more pain intensity.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2018
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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