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

Recruiting Phase 3 Interventional Study
Orthopedic Trauma Sleep Quality
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
30 (estimated)
Sponsor
Emory University · Other
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About 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…
Trial Locations
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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 Exclusi…
Contacts

Mara Schenker, MD

404-778-1550

mara.schenker@emory.edu

CONTACT

Tyler Edmond, MD

tjedmon@emory.edu

CONTACT