Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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.
Participants will:
* Receive either the multimodal sleep pathway (zolpidem, melatonin, and sleep hygiene education) or standard care * Wear a wrist-worn actigraphy device to track sleep during their hospital stay * Complete daily questionnaires about sleep quality and pain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Postoperative Care
Other interventionIncludes routine pain management and nursing care
Zolpidem
Drug* 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
Melatonin
Dietary supplement* Dose: 3 mg * Administration: Taken 30 minutes before bedtime * Purpose: Supports circadian regulation and sleep continuity
Sleep Hygiene Education
Behavioral* 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
DeviceThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Multimodal Sleep PathwayExperimental treatment 4 interventions
Group B: Standard CareOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Daily during inpatient hospitalization (approximately 3-7 days)2
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.
Time frame
Daily during inpatient hospitalization (approximately 3-7 days)3
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.
Time frame
Daily during inpatient hospitalization (approximately 3-7 days)4
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).
Time frame
Daily during inpatient hospitalization (approximately 3-7 days)Secondary outcomes
1
Pain Interference
Patient-reported pain interference with daily activities measured using a validated pain interference scale. Higher scores indicate greater interference
Time frame
Daily during inpatient hospitalization (approximately 3-7 days)2
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.
Time frame
Throughout the study (upto 7 days of hospital stay)3
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.
Time frame
Throughout the study (upto 7 days of hospital stay)4
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.
Time frame
Throughout the study (upto 7 days of hospital stay)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
AO North America
Collaborator
Source ClinicalTrials.gov