Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Pa… (NCT07336277) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
United States30 participantsStarted 2026-06
Plain-language 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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a 'multimodal sleep pathway' for orthopedic trauma patients in the hospital — can you explain what that pathway actually involves day-to-day, and whether it would change how my pain or sleep medications are managed during my stay?
2Since this trial is tracking daily opioid use as one of its main outcomes, does that mean there's a possibility my pain medication could be reduced or changed as part of the study, and how would my comfort be protected if that happens?
3The trial isn't recruiting yet — do you know when it's expected to open, and given my situation, is it realistic to wait for it or should we be making treatment and recovery decisions now?
4The study measures both objective sleep data and how I personally feel I'm sleeping using questionnaires — can you walk me through what that would require from me while I'm recovering from an orthopedic injury, and is that realistic given how I'm feeling?
5Compared to just being cared for normally in the hospital without being in a study, what do you think I might gain or lose by participating in this trial, especially since it's Phase 3 and we may not yet have full safety and effectiveness data?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Sleep Time
Timeframe: Daily during inpatient hospitalization (approximately 3-7 days)
2
Sleep Efficiency
Timeframe: Daily during inpatient hospitalization (approximately 3-7 days)
3
Number of Awakenings
Timeframe: Daily during inpatient hospitalization (approximately 3-7 days)
4
Subjective Sleep Quality: PROMIS scale
Timeframe: Daily during inpatient hospitalization (approximately 3-7 days)