Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Trauma Clinical Trial

Official title:

Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779243
• Other study ID #: IRB-48700
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Trauma
• Wounds and Injuries

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