NCT05746143 The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
| NCT ID | NCT05746143 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Southern California |
| Condition | Spine Fusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2022-02-01 with a primary completion date of 2029-01-31.
⚠ 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 purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.
Eligibility Criteria
Inclusion Criteria: * degenerative lumbar disease * age of 18-75 * undergoing open primary one- to three-level lumbar fusion Exclusion Criteria: * currently use a sleep aid nightly * diagnosed with insomnia or sleep apnea * history of delirium with opiates or zolpidem * allergic to opiates or zolpidem * had previous lumbar spine surgery * undergoing minimally invasive lumbar fusion, * undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05746143 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spine Fusion. 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 NCT05746143 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05746143 currently recruiting?
Yes, NCT05746143 is actively recruiting participants. Contact the research team at puiyan@med.usc.edu for enrollment information.
Where is the NCT05746143 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05746143 clinical trial?
NCT05746143 is sponsored by University of Southern California. The trial plans to enroll 140 participants.