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

Recruiting now · Phase 3

Conditions studied: Orthopedic Trauma, Sleep Quality

In brief

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

Key facts

Study ID

NCT07336277

Run by

Emory University

People needed

30

Starts

2026-06-02

Expected to finish

2027-07-01

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Emory University — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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