Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Study Overview
=================
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 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.

Official Title
-----------------
Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Conditions
-----------------
Trauma, Sleep Disturbance

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin 5mg and Sleep Education
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5mg Melatonin and Sleep Education<br>Participants will take 5mg Melatonin nightly, 1 hour before bedtime and be provided educational materials to improve sleep hygiene. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits. | Dietary Supplement: Melatonin 5mg and Sleep Education<br>* Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.<br>|
| Placebo Comparator: Placebo Control<br>Participants will be given placebo pills to be taken daily 1 hour before bedtime and are a sleep aid. Participants will not receive any sleep education materials. They will have study visits in clinic as part of standard-of-care at 6 weeks and 12 weeks. They will complete Pittsburgh Sleep Quality Index and SF-36 Quality of Life questionnaires at enrollment and at their clinic visits. | Other: Placebo<br>* Daily placebo pills for 6 weeks following injury or surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |