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

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

• Orthopedic Trauma
• Sleep Quality

Interventions

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.

Sponsors & Collaborators

• AO North America

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Mara Schenker, MD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2026-07-31

Completion

2026-07-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations