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New sleep plan aims to cut opioid use in orthopedic patients

NCT ID NCT07336277

Symptom relief Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a sleep program for people hospitalized after a leg injury that needed surgery. The program includes sleep medicine, melatonin, and sleep tips. Researchers want to see if it helps patients sleep longer and better, and if it reduces the need for strong painkillers. About 30 adults will take part, and their sleep will be tracked with a wrist device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

injury insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Orthopedic trauma Sleep quality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30324, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.