Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
Who can join
Ages 18 to 65 · All sexes
Full 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.
About the study
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
What is being tested
- Standard Postoperative Care (other)
- Zolpidem (drug)
- Melatonin (dietary supplement)
- Sleep Hygiene Education (behavioral)
- Actigraph GT3X-BT Actigraph (device)
Sponsor: Emory University · Participants: 30 · Started: Jun 2, 2026
Contact the study team
- Mara Schenker, MD · Phone: 404-778-1550
Official record on ClinicalTrials.gov — NCT07336277
Locations in the U.S.
| Georgia | Emory University, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.