NCT07336277

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 only two nights of partial sleep deprivation and continues to worsen with each additional night. Despite these established interactions, objective sleep metrics have not been well characterized in the orthopedic trauma inpatient population, where postoperative pain, environmental disruptions, and medication use may all contribute to sleep disturbance. Sleep patterns are also influenced by psychoactive substances, including opioids. Substance use and sleep-wake regulation share overlapping neurobiological pathways, and disruptions in circadian rhythms can occur during substance use, withdrawal, or detoxification. Although the mechanisms by which opioids alter sleep architecture are not fully understood, prior studies have shown that opioid exposure reduces restorative sleep stages, including deep sleep and rapid eye movement (REM) sleep, while increasing lighter stage-2 sleep. These changes may contribute to fragmented sleep and impaired recovery in postoperative patients who rely on opioids for pain management. Non-opioid strategies have shown promise in improving sleep quality in hospitalized and postoperative patient populations. Behavioral approaches such as relaxation techniques, stimulus control, and structured sleep hygiene have been associated with improvements in sleep duration and continuity. Pharmacologic alternatives, including zolpidem and melatonin, have demonstrated benefit in orthopedic and general adult populations by supporting sleep initiation, circadian regulation, and overall sleep quality. This study builds on these findings through two complementary aims. Aim 1 analyzes previously collected actigraphy and survey data from a randomized controlled trial of adults with isolated orthopedic injuries (NCT04154384). In that study, participants wore wrist-worn actigraphy devices during hospitalization and completed validated sleep and pain assessments at baseline and postoperative follow-up visits. Preliminary analyses indicate that patients experience short, fragmented sleep and that higher opioid utilization may be associated with decreased sleep quantity and quality. Further analysis is needed to characterize these relationships using objective sleep metrics and detailed opioid timing and dosing data. Aim 2 evaluates a multimodal sleep pathway designed to improve sleep quality and reduce opioid use during inpatient recovery. In a prospective randomized controlled trial, participants are assigned to receive either standard postoperative care or a sleep pathway that includes low-dose zolpidem, melatonin, and structured sleep hygiene education. The intervention begins on the first postoperative night and continues daily until discharge. Sleep outcomes are assessed using daily subjective questionnaires and continuous wrist actigraphy. Opioid consumption is recorded and converted to morphine milligram equivalents to allow standardized comparison. Pain perception is measured using validated patient-reported tools. Feasibility outcomes include recruitment, adherence to the intervention, actigraphy wear compliance, and retention through discharge. Safety monitoring includes assessment for medication-related side effects and actigraphy-related discomfort. Together, these aims will provide foundational data on the relationship between opioid use and sleep quality in orthopedic trauma patients and will evaluate whether a structured multimodal sleep intervention can improve sleep and reduce reliance on opioids during hospitalization. Findings will inform the design of future larger-scale trials aimed at optimizing sleep and recovery in this population.

Conditions

• Orthopedic Trauma
• Sleep Quality

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-01-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study