NCT07336277 Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
| NCT ID | NCT07336277 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Emory University |
| Condition | Orthopedic Trauma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 30 participants in total. It began in 2026-06-02 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 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.
Contact & Investigator
Mara Schenker, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT07336277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Orthopedic Trauma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07336277 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 30 participants.
Is NCT07336277 currently recruiting?
Yes, NCT07336277 is actively recruiting participants. Contact the research team at mara.schenker@emory.edu for enrollment information.
Where is the NCT07336277 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07336277 clinical trial?
NCT07336277 is sponsored by Emory University. The principal investigator is Mara Schenker, MD at Emory University. The trial plans to enroll 30 participants.