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Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

Primary Purpose

Sleep Disturbance, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melatonin 5mg and Sleep Education
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

5mg Melatonin and Sleep Education

Placebo Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 16, 2018
Last Updated
December 1, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03779243
Brief Title
Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
Official Title
Melatonin Treatment for Sleep Disturbance in Orthopaedic Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
August 24, 2021 (Actual)
Study Completion Date
August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
double-blind
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5mg Melatonin and Sleep Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin 5mg and Sleep Education
Intervention Description
Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily placebo pills for 6 weeks following injury or surgery.
Primary Outcome Measure Information:
Title
Mean Change in Pittsburgh Sleep Quality Index Score
Description
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.
Time Frame
Baseline, week 6, and week 12
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey (SF-36) to measure quality of life
Description
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.
Time Frame
Baseline, week 6, and week 12
Title
Mean Change from Baseline in Pain Scores on the Visual Analog Scale (VAS)
Description
VAS is scored on a continuum from 0-10 indicating "no pain" to "unbearable pain". Higher scores indicate more pain intensity.
Time Frame
Baseline, week 6, and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Gardner, MD
Organizational Affiliation
Stanford Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30086043
Citation
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.
Results Reference
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Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

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