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הניסוי הקליני NCT07336277 עבור Orthopedic Trauma, איכות השינה הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים

Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients שלב III 30

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07336277 מתוכנן לבדוק את טיפול תומך עבור Orthopedic Trauma, איכות השינה. זהו מחקר שלב III מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 במרץ 2026, במטרה לכלול 30 משתתפים. המחקר ינוהל על ידי אוניברסיטת אמורי וצפוי להסתיים ב-1 ביולי 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-13 בפברואר 2026.
סיכום קצר

The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma. It will also evaluate the effect of this pathway on opioid use and pain perception during recovery.

The main study questions are:

  • Does the multimodal sleep pathway improve sleep quality and duration?
  • Does the pathway reduce the amount of opioids patients use during...
הצג עוד
תיאור מפורט
Post-surgical orthopedic trauma patients frequently experience significant sleep disturbances, including reduced sleep quality, increased nighttime awakenings, and shortened sleep duration. Sleep and pain have a bidirectional relationship in which poor sleep increases pain sensitivity, and higher pain levels further disrupt sleep. Experimental sleep-restriction studies have shown that pain perception increases after ...הצג עוד
כותרת רשמית

Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients

מצבים רפואיים
Orthopedic Traumaאיכות השינה
מזהי מחקר נוספים
  • 2025P012693
מספר NCT
תחילת המחקר (בפועל)
2026-03
עדכון אחרון שפורסם
2026-02-13
סיום המחקר (מוערך)
2026-07
משתתפים (מתוכנן)
30
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
טרם החל גיוס
מילות מפתח
Multimodal Sleep Pathway
Sleep Quality
Opioid consumption
מטרה ראשית
טיפול תומך
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
משולש
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיMultimodal Sleep Pathway
Participants receive a multimodal sleep pathway consisting of pharmacologic sleep aids and non-pharmacologic sleep hygiene education beginning on the first postoperative night and continuing daily until hospital discharge.
Zolpidem
* Dose: 5 mg * Administration: Taken nightly at bedtime * Purpose: Supports sleep initiation as part of the multimodal sleep pathway * Additional Notes: FDA-approved sedative-hypnotic used short-term for insomnia
מלטונין
* Dose: 3 mg * Administration: Taken 30 minutes before bedtime * Purpose: Supports circadian regulation and sleep continuity
חינוך להיגיינת שינה
* Components: Guidance on consistent sleep schedules, minimizing nighttime disruptions, reducing screen exposure before bed, and optimizing environmental factors (light, noise, temperature) * Delivery: Provided by research staff daily during hospitalization
Actigraph GT3X-BT Actigraph
The ActiGraph GT3X-BT (ActiGraph, LLC; Pensacola, FL) is a lightweight, wrist-worn accelerometer used to objectively measure sleep-wake patterns in hospitalized patients. The device continuously records movement data that are processed using validated algorithms to estimate total sleep time, sleep efficiency, and number of awakenings.
אחרStandard Care
Participants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion.
Standard Postoperative Care
Includes routine pain management and nursing care
Actigraph GT3X-BT Actigraph
The ActiGraph GT3X-BT (ActiGraph, LLC; Pensacola, FL) is a lightweight, wrist-worn accelerometer used to objectively measure sleep-wake patterns in hospitalized patients. The device continuously records movement data that are processed using validated algorithms to estimate total sleep time, sleep efficiency, and number of awakenings.
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Total Sleep Time
Total minutes of sleep obtained each night, measured continuously using a wrist-worn actigraphy device (Actigraph GT3X-BT). Between-group differences in total sleep time will be evaluated using independent t-tests or Mann-Whitney U tests, depending on distribution. Longitudinal changes will be analyzed using linear mixed-effects models with random intercepts to account for repeated measures. Covariates may include age, injury characteristics, and baseline pain levels.
Daily during inpatient hospitalization (approximately 3-7 days)
Sleep Efficiency
Percentage of time spent asleep while in bed, calculated from actigraphy data collected continuously during hospitalization. Group comparisons will be conducted using independent t-tests or nonparametric equivalents. Mixed-effects modeling will assess within-subject changes over time and the effect of group assignment.
Daily during inpatient hospitalization (approximately 3-7 days)
Number of Awakenings
Total number of nighttime awakenings detected by actigraphy, reflecting sleep fragmentation. Awakening counts will be compared between groups using Poisson or negative binomial regression models, depending on dispersion. Mixed-effects count models will evaluate changes over time.
Daily during inpatient hospitalization (approximately 3-7 days)
Subjective Sleep Quality: PROMIS scale
The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. Items are rated on 5-point Likert scales and summed to produce a raw score, which is converted to a standardized PROMIS T-score. Higher T-scores indicate greater sleep disturbance (worse sleep), and lower T-scores indicate less sleep disturbance (better sleep).
Daily during inpatient hospitalization (approximately 3-7 days)
Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)
The LSEQ is a 10-item patient-reported questionnaire that assesses subjective changes in sleep and early-morning functioning using 100-mm visual analogue scales. Items evaluate four domains: Getting to Sleep (GTS), Quality of Sleep (QOS), Awakening From Sleep (AFS), and Behavior Following Waking (BFW). Each item is scored from 0-100 mm, with higher scores indicating greater improvement relative to usual sleep and lower scores indicating worsening.
Daily during inpatient hospitalization (approximately 3-7 days)
Daily Opioid Utilization
Total opioid consumption recorded from the medical record and converted to morphine milligram equivalents (MMEs) to allow standardized comparison across medication types and dosing regimens.
Daily during inpatient hospitalization (approximately 3-7 days)
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Pain Interference
Patient-reported pain interference with daily activities measured using a validated pain interference scale. Higher scores indicate greater interference
Daily during inpatient hospitalization (approximately 3-7 days)
Recruitment Feasibility
Assesses the proportion of eligible orthopedic trauma patients who enroll in the study during the inpatient recruitment window. Recruitment feasibility reflects the practicality of identifying, approaching, and enrolling participants in an acute trauma setting. Recruitment rate will be calculated as the number of enrolled participants divided by the number of eligible patients approached. Results will be summarized using proportions and 95% confidence intervals.
Throughout the study (upto 7 days of hospital stay)
Adherence to Pharmacologic Components
Assesses adherence to the medication components of the multimodal sleep pathway, defined as the proportion of nights during which participants receive the prescribed low-dose zolpidem and melatonin as ordered. Adherence will be summarized as the percentage of scheduled doses administered. Means, standard deviations, and proportions will be reported.
Throughout the study (upto 7 days of hospital stay)
Adherence to Non-Pharmacologic Components
Assesses adherence to daily sleep hygiene education, including completion of brief educational sessions delivered by research staff. Adherence reflects the feasibility of implementing behavioral components in a busy inpatient trauma environment. Adherence will be summarized descriptively as the proportion of days on which sleep hygiene education was completed. Percentages and confidence intervals will be reported.
Throughout the study (upto 7 days of hospital stay)
Actigraphy Wear-Time Compliance
Assesses the proportion of hospitalization hours during which the ActiGraph GT3X-BT device records valid data. This measure assesses the feasibility and tolerability of continuous wrist-worn actigraphy in patients with orthopedic trauma. Wear-time compliance will be calculated as the percentage of total hospitalization hours with valid actigraphy data. Descriptive statistics (means, SDs, ranges) will be reported.
Throughout the study (upto 7 days of hospital stay)
Retention Through Discharge
Assesses the proportion of enrolled participants who complete all study procedures through hospital discharge without withdrawal or protocol discontinuation. Retention will be summarized as the percentage of participants completing the study through discharge. Proportions and 95% confidence intervals will be reported.
Throughout the study (upto 7 days of hospital stay)
Adverse Events Related to Study Interventions
Incidence of medication-related side effects (e.g., dizziness, drowsiness, complex sleep behaviors), melatonin intolerance, or actigraphy-related discomfort. Adverse events will be summarized using frequencies and proportions. Between-group comparisons may use Fisher's exact test.
Throughout the study (upto 7 days of hospital stay)
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • Hospitalized with an isolated lower extremity orthopedic injury requiring surgical intervention.
  • Expected hospital stay of at least 3 days.
  • No known pre-existing sleep disorders.
  • No current use of sleep aids, such as zolpidem or melatonin, before hospitalization

  • Participants with a history of chronic opioid use prior to hospitalization.
  • Pre-existing diagnosed sleep disorders (e.g., obstructive sleep apnea, insomnia).
  • Contraindications to zolpidem or melatonin use (e.g., allergies, interactions with other medications).
  • Cognitive impairment or inability to comply with study procedures.
  • Severe traumatic brain injury or other neurological conditions that may affect sleep or pain perception.
  • Participants receiving mechanical ventilation or sedatives that significantly affect sleep architecture.
Emory University logoאוניברסיטת אמורי
AO North America logoAO North America
הגורם האחראי למחקר
Mara Schenker, חוקר ראשי, Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Mara Schenker, MD, 404-778-1550, [email protected]
איש קשר: Tyler Edmond, MD, [email protected]
1 מיקומי המחקר ב-1 מדינות

Georgia

Emory University, Atlanta, Georgia, 30324, United States
Mara Schenker, MD, איש קשר, 404-778-1550, [email protected]
Tyler Edmond, MD, איש קשר, [email protected]