Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Standard Postoperative Care
  • Zolpidem
  • Melatonin
  • Sleep Hygiene Education
  • Actigraph GT3X-BT Actigraph

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

AO North America

Collaborator