Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

NCT03779243 | Completed

• 1 other identifier: IRB-48700
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline, week 6, and week 12

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

  Baseline, week 6, and week 12

Study Arms (2)

5mg Melatonin and Sleep Education

EXPERIMENTAL

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

Placebo Control

PLACEBO COMPARATOR

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

Interventions

Melatonin 5mg and Sleep Education DIETARY_SUPPLEMENT

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

5mg Melatonin and Sleep Education

Placebo OTHER

Daily placebo pills for 6 weeks following injury or surgery.

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Stanford, California, 94305, United States

Location

Related 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.

  PMID: 30086043 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Wounds and Injuries

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Michael J Gardner, MD

  Stanford Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR OF ORTHOPAEDIC SURGERY AT THE STANFORD UNIVERSITY MEDICAL CENTER

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: January 7, 2019
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)