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

NCT ID: NCT07336277

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Multimodal 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.

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

• Dose: 3 mg
• Administration: Taken 30 minutes before bedtime
• Purpose: Supports circadian regulation and sleep continuity

Sleep Hygiene Education

Intervention Type: 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

Intervention Type: DEVICE

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.

Standard Care

Participants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion.

Group Type: OTHER

Standard Postoperative Care

Intervention Type: OTHER

Includes routine pain management and nursing care

Actigraph GT3X-BT Actigraph

Intervention Type: DEVICE

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.

Interventions

Standard Postoperative Care

Includes routine pain management and nursing care

Intervention Type: OTHER

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

Intervention Type: DRUG

Melatonin

• Dose: 3 mg
• Administration: Taken 30 minutes before bedtime
• Purpose: Supports circadian regulation and sleep continuity

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO North America

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Mara Schenker

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mara Schenker, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Mara Schenker, MD

Role: CONTACT

mara.schenker@emory.edu

404-778-1550

Tyler Edmond, MD

Role: CONTACT

tjedmon@emory.edu

Facility Contacts

Mara Schenker, MD

Role: primary

mara.schenker@emory.edu

404-778-1550

Tyler Edmond, MD

Role: backup

tjedmon@emory.edu

Other Identifiers

2025P012693

Identifier Type: -

Identifier Source: org_study_id