Multimodal Sleep Pathway for Fracture Recovery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether the Multimodal Sleep Pathway, a special sleep plan, can aid hospital patients recovering from leg or hip fractures. Researchers aim to determine if this plan, which includes sleep aids and tips for better sleep, improves sleep quality and reduces painkiller use. The trial compares this new plan with regular hospital care to see if better sleep results in less pain interference with daily activities. Patients who have undergone surgery for a leg or hip injury and do not already use sleep aids or have sleep disorders might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be using sleep aids like zolpidem or melatonin before joining. If you are on these, you may need to stop them to participate.
Is there any evidence suggesting that the multimodal sleep pathway is likely to be safe for humans?
Research has shown that a combined approach to improving sleep, which includes zolpidem, melatonin, and education on good sleep habits, is well-tolerated by patients with bone injuries. A study on a similar sleep treatment found it safe for individuals recovering from shoulder surgery, indicating that the treatment poses no major safety concerns. Zolpidem and melatonin, both integral to this approach, are common sleep aids with well-established safety records, enhancing confidence in the treatment's general safety for patients.12345
Why are researchers excited about this trial?
Researchers are excited about the Multimodal Sleep Pathway because it combines both pharmacologic sleep aids and non-pharmacologic sleep hygiene education, offering a comprehensive approach to help patients recover from fractures. Unlike standard postoperative care, which typically focuses on pain management without specific sleep interventions, this pathway targets sleep quality starting from the first night after surgery. By improving sleep, the treatment aims to enhance overall recovery and well-being, potentially reducing hospital stays and improving patient outcomes.
What evidence suggests that the multimodal sleep pathway is effective for improving sleep quality in orthopedic trauma patients?
This trial will compare a Multimodal Sleep Pathway with standard care for fracture recovery. Research has shown that a combined approach to sleep, using sleep aids like zolpidem and melatonin along with sleep hygiene education, can improve sleep in hospitalized patients. Participants receiving the Multimodal Sleep Pathway will experience this combined approach. Studies have found that this method not only enhances sleep but also reduces the need for painkillers during recovery. Better sleep is linked to less pain and improved daily functioning. Evidence suggests that patients using this approach experience less pain interfering with their daily activities. Overall, this combined sleep method appears promising for improving recovery in patients with orthopedic injuries.12678
Who Is on the Research Team?
Mara Schenker, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for hospitalized orthopedic trauma patients who are experiencing sleep issues. To join, they must be willing to wear a wrist device that tracks sleep and fill out daily questionnaires about their sleep quality and pain levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the multimodal sleep pathway or standard care during their hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Multimodal Sleep Pathway
Trial Overview
The study tests if a 'multimodal sleep pathway' (including zolpidem, melatonin, and education on good sleeping habits) improves sleep better than standard care after surgery. It also looks at whether this can reduce opioid use and lessen pain during recovery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion.
Participants receive a multimodal sleep pathway consisting of pharmacologic sleep aids and non-pharmacologic sleep hygiene education beginning on the first postoperative night and continuing daily until hospital discharge.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
AO North America
Collaborator
Citations
Sleep Quality and the Efficacy of a Multimodal ...
The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic ...
Multimodal Sleep Pathway for Fracture Recovery
The goal of this study is to determine whether a multimodal sleep pathway can enhance sleep quality in hospitalized patients with orthopedic trauma.
Multimodal sleep management reduces perioperative ...
These results highlight the effectiveness of the OHE-based program in improving sleep quality, accelerating recovery, and enhancing patient satisfaction in ...
Effect of preoperative sleep quality on rapid postoperative ...
Conclusion: Maintaining good sleep quality before surgery can alleviate early postoperative pain, reduce the risk of postoperative anxiety and ...
Original Article Effects of multimodal pain management in ...
Conclusion: Multimodal pain management for patients with long bone fracture is conducive to pain relief, sleep quality improvement, negative ...
Orthopedic sleep and novel analgesia pathway
This study involved an emphasis on an interventional sleep pathway along with this multimodal analgesia following TSA and demonstrated it to be safe with ...
Multimodal Evaluation of Sleep Health and Disruptions and ...
Sleep Following a Stroke: Multimodal Evaluation of Sleep Health and Disruptions and Impact on Recovery During Acute Inpatient Rehabilitation.
Multimodal Sleep Pathway for Shoulder Arthroplasty
The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators ...
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