Sleep quality improvement with a multimodal pathway after orthopedic trauma
Official title: Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
Run by Emory University · NCT07336277 · Data updated 2026-11-12
This study tests whether a multimodal sleep pathway ( zolpidem, melatonin, and sleep hygiene education ) can improve sleep and reduce opioid use for patients recovering from orthopedic trauma in the hospital.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07336277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with isolated lower-extremity orthopedic injuries requiring surgery and a hospital stay of at least 3 days, who have no pre-existing sleep disorders or use of sleep aids.
✕Probably not a fit
Patients with contraindications to zolpidem/melatonin, pre-existing sleep disorders, chronic opioid use, or inability to participate in study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 3 trial, hospitalized adults with isolated lower-extremity orthopedic injuries undergoing surgery will be randomized to receive either the multimodal sleep pathway or standard postoperative care. The pathway includes zolpidem, melatonin, and sleep hygiene education, plus wrist actigraphy to monitor sleep. Researchers will measure sleep quality and duration, opioid consumption, and how sleep impacts daily activities during recovery. Daily sleep and pain questionnaires will track patient-reported outcomes alongside objective sleep data.
Why it matters
Potential benefit: If successful, patients may sleep better, require fewer opioids, and experience less pain-related disruption to daily activities.
How similar studies have gone: Prior work suggests sleep interventions can affect sleep quality and pain, but results in orthopedic trauma with objective sleep monitoring are still being established.
Who can join: the full rules
Show full inclusion / exclusion 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 Exclusion Criteria: * 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's running
-
Emory University
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Mara Schenker, MD — Emory University
- Study coordinator: Mara Schenker, MD
- Email: mara.schenker@emory.edu
- Phone: 404-778-1550
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.