Multimodal Sleep Pathway for Fracture Recovery

Overseen By Tyler Edmond, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Emory University

Must not be taking: Sleep aids, Sedatives

Disqualifiers: Chronic opioid use, Sleep disorders, Cognitive impairment, Severe brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-7 days

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

Mara Schenker, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for hospitalized orthopedic trauma patients who are experiencing sleep issues. To join, they must be willing to wear a wrist device that tracks sleep and fill out daily questionnaires about their sleep quality and pain levels.

Inclusion Criteria

Expected hospital stay of at least 3 days

I do not have any known sleep disorders.

I am not currently using any sleep aids like zolpidem or melatonin.

Exclusion Criteria

Participants with a history of chronic opioid use prior to hospitalization

I have been diagnosed with a sleep disorder like sleep apnea or insomnia.

I do not have cognitive issues affecting my ability to follow study procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the multimodal sleep pathway or standard care during their hospital stay

3-7 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Sleep Pathway

Trial Overview

The study tests if a 'multimodal sleep pathway' (including zolpidem, melatonin, and education on good sleeping habits) improves sleep better than standard care after surgery. It also looks at whether this can reduce opioid use and lessen pain during recovery.

How Is the Trial Designed?

Group I: Standard Care Experimental Treatment 2 Interventions

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

Group II: Multimodal Sleep Pathway Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

AO North America

Collaborator

Trials

3

Recruited

140+