NCT07336277 · Emory University
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
What this study is about
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.
View original scientific description
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 hospitalization? * Does improved sleep reduce pain interference with daily activities? Researchers will compare the multimodal sleep pathway to standard postoperative care to see if the pathway helps patients sleep better and rely less on opioids.
Interventions
OTHER
Standard Postoperative Care
Includes routine pain management and nursing care
DRUG
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
DIETARY_SUPPLEMENT
Melatonin
* Dose: 3 mg * Administration: Taken 30 minutes before bedtime * Purpose: Supports circadian regulation and sleep continuity
BEHAVIORAL
Sleep Hygiene Education
* 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
DEVICE
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.
Primary outcome measures
Total Sleep Time
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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.
Sleep Efficiency
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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.
Number of Awakenings
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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.
Subjective Sleep Quality: PROMIS scale
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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).
Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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 Opioid Utilization
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Atlanta, Georgia
Collaborators
AO North America
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations