Trial studying safety and effects for Orthopedic Trauma
Official title Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
ClinicalTrials.gov ID: NCT07336277
What this study is testing
What is Zolpidem?
An investigational sleep‑helping medication being studied to improve sleep quality in patients hospitalized for orthopedic trauma. It is designed to bind to GABA‑A receptors and promote sleep onset.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new sleep plan helps patients sleep better. It also checks if this plan lowers the need for pain medicine.
- Who it's for
- You may be able to join if you are in the hospital for a bone injury.
- What's involved
- You would get a sleep plan or usual care. You would wear a wrist tracker and fill out daily forms about sleep and pain.
- Time commitment
- You take part while you are in the hospital for your injury.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.