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NCT07336277 · ClinicalTrials.gov registry record · Phase 3
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
A Phase 3 study, sponsored by Emory University.
- Not yet
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT07336277: Clinical Trial Phase 3 study, sponsored by Emory University.
NCT07336277 is a Phase 3 study that has not yet begun recruiting, run by Emory University. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07336277, a Phase 3 study, has not yet begun recruiting, sponsored by Emory University.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study 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
Primary Outcome
Total minutes of sleep obtained each night, measured continuously using a wrist-worn actigraphy device (Actigraph GT3X-BT). Between-group differences in total sleep time will be evaluated using independent t-tests or Mann-Whitney U tests, depending on distribution. Longitudinal changes will be analyzed using linear mixed-effects models with random intercepts to account for repeated measures. Covariates may include age, injury characteristics, and baseline pain levels.
Interventions
- DIETARY_SUPPLEMENT Melatonin
- DRUG Zolpidem
- BEHAVIORAL Sleep Hygiene Education
- OTHER Standard Postoperative Care
- DEVICE Actigraph GT3X-BT Actigraph
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-06 |
| Est. Completion | 2026-07 |
| Phase | Phase 3 |
What is known before NCT07336277 opens enrollment
NCT07336277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Melatonin is the first listed.
NCT07336277 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07336277 about?
NCT07336277 is a clinical study titled "Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients". 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 multimod...
What is the current status of trial NCT07336277?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2026-06. Estimated completion is 2026-07.
What interventions are being tested in trial NCT07336277?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Zolpidem (DRUG), Sleep Hygiene Education (BEHAVIORAL), Standard Postoperative Care (OTHER), Actigraph GT3X-BT Actigraph (DEVICE).
Who is sponsoring clinical trial NCT07336277?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07336277's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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