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

NCT07336277 | Not Yet Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: 2025P012693
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Quality; Orthopedic Trauma

Keywords

Multimodal Sleep Pathway; Sleep Quality; Opioid consumption

Outcome Measures

Primary Outcomes (6)

• 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.

  Daily during inpatient hospitalization (approximately 3-7 days)

• 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.

  Daily during inpatient hospitalization (approximately 3-7 days)

• 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.

  Daily during inpatient hospitalization (approximately 3-7 days)

• 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).

  Daily during inpatient hospitalization (approximately 3-7 days)

• Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)

  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 during inpatient hospitalization (approximately 3-7 days)

• Daily Opioid Utilization

  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.

  Daily during inpatient hospitalization (approximately 3-7 days)

Secondary Outcomes (7)

• Pain Interference

  Daily during inpatient hospitalization (approximately 3-7 days)

• Recruitment Feasibility

  Throughout the study (upto 7 days of hospital stay)

• Adherence to Pharmacologic Components

  Throughout the study (upto 7 days of hospital stay)

• Adherence to Non-Pharmacologic Components

  Throughout the study (upto 7 days of hospital stay)

• Actigraphy Wear-Time Compliance

  Throughout the study (upto 7 days of hospital stay)

Study Arms (2)

Multimodal Sleep Pathway

EXPERIMENTAL

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.

Drug: Zolpidem; Dietary Supplement: Melatonin; Behavioral: Sleep Hygiene Education; Device: Actigraph GT3X-BT Actigraph

Standard Care

OTHER

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

Other: Standard Postoperative Care; Device: Actigraph GT3X-BT Actigraph

Interventions

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

Multimodal Sleep Pathway

Melatonin DIETARY_SUPPLEMENT

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

Multimodal Sleep Pathway

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

Multimodal Sleep Pathway

Actigraph GT3X-BT Actigraph 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.

Multimodal Sleep Pathway; Standard Care

Standard Postoperative Care OTHER

Includes routine pain management and nursing care

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• AO North America: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30324, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem; Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mara Schenker, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Schenker, MD

CONTACT

404-778-1550; mara.schenker@emory.edu

Tyler Edmond, MD

CONTACT

tjedmon@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon completion of the study.
• Access Criteria: Reaching out to the PI.

Locations

US (1)