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

StatusRecruiting
PhasePhase 3
Started2026-06-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from Emory University

Amendment history

2026-07-29
critical
Study Status, Contacts/Locations v3
Recruitment opened
Primary completion pushed: 2026-07 → 2027-07
Completion pushed: 2026-07 → 2027-07
Start dateestimated 2026-06→confirmed 2026-06-02
Study sitesdetails revised at 1 of 1 site
2026-05-05
minor
Study Status v2
Start date2026-03→2026-06
2026-02-11
minor
Study Status v1
Start date2026-01→2026-03
2026-01-10
minor
Original filing
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
Trial Details
NCT Number NCT07336277
Lead Sponsor Emory University
Collaborators: AO North America
Conditions Orthopedic Trauma, Sleep Quality
Enrollment 30 participants
Start Date 2026-06-02
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-30