Sleep Disturbance, Trauma
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMelatonin 5mg and Sleep Education
Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
OTHERPlacebo
Daily placebo pills for 6 weeks following injury or surgery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pittsburgh Sleep Quality Index Score | 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
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Survey (SF-36) to measure quality of life | 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. |
| Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS) | 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. |
Countries
United States
Outcome results
None listed