Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Not Applicable

Completed

• Conditions: Sleep Disturbance; Trauma
• Interventions: Dietary Supplement: Melatonin 5mg and Sleep Education; Other: Placebo

• Registration Number: NCT03779243
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Study Start: 2019-01-07
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5mg Melatonin and Sleep Education	Melatonin 5mg and Sleep Education	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.
Placebo Control	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford; 🇺🇸 Stanford, California, United States