Sleep Quality in Hospitalized Orthopedic Trauma Patients
This study is looking at whether a special approach to sleep can improve sleep quality for people hospitalized after lower leg orthopedic surgery. This approach, called a "multimodal sleep pathway," includes standard care, a sleep medication called Zolpidem (5 mg nightly), a supplement called Melatonin (3 mg before bed), and daily sleep hygiene education (guidance on good sleep habits). Researchers will compare this pathway to standard care alone. They want to see if this pathway helps you sleep better, reduces the amount of pain medication (opioids) you need, and lessens how much pain interferes with your daily activities. You might be able to join if you are 18-65 years old, are hospitalized for a lower leg orthopedic injury requiring surgery, and expect to stay at least 3 days. You should not have pre-existing sleep disorders or be using sleep aids before hospitalization. The study status is currently unclear.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It compares a multimodal sleep pathway to standard postoperative care.
- What's involved
- You would receive daily sleep hygiene education during your hospitalization. Your sleep-wake patterns will be measured daily using a wrist-worn device (Actigraph GT3X-BT Actigraph) during your inpatient stay, which is expected to be approximately 3-7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sleep will be measured daily during your inpatient hospitalization, which is expected to last approximately 3-7 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mara Schenker, MD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Total Sleep TimeDaily 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 EfficiencyDaily 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 AwakeningsDaily 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 scaleDaily 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)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 UtilizationDaily 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.