Orthopedic TraumaPhase 3NCT07336277
Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
A Phase 3 study testing Standard Postoperative Care, Zolpidem and Melatonin in people with Orthopedic Trauma and Sleep Quality, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Trauma, Sleep Quality
- What is being tested?
- Standard Postoperative Care, Zolpidem and Melatonin
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2026to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tyler Edmond, MD contact
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30324
Mara Schenker, MD, 404-778-1550, mara.schenker@emory.edu
Tyler Edmond, MD, tjedmon@emory.edu
About this study
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:
Read more
- 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
Read the detailed description
Post-surgical orthopedic trauma patients frequently experience significant sleep disturbances, including reduced sleep quality, increased nighttime awakenings, and shortened sleep duration. Sleep and pain have a bidirectional relationship in which poor sleep increases pain sensitivity, and higher pain levels further disrupt sleep. Experimental sleep-restriction studies have shown that pain perception increases after only two nights of partial sleep deprivation and continues to worsen with each additional night. Despite these established interactions, objective sleep metrics have not been well characterized in the orthopedic trauma inpatient population, where postoperative pain, environmental disruptions, and medication use may all contribute to sleep disturbance.
Sleep patterns are also influenced by psychoactive substances, including opioids. Substance use and sleep-wake regulation share overlapping neurobiological pathways, and disruptions in circadian rhythms can occur during substance use, withdrawal, or detoxification. Although the mechanisms by which opioids alter sleep architecture are not fully understood, prior studies have shown that opioid exposure reduces restorative sleep stages, including deep sleep and rapid eye movement (REM) sleep, while increasing lighter stage-2 sleep. These changes may contribute to fragmented sleep and impaired recovery in postoperative patients who rely on opioids for pain management.
Non-opioid strategies have shown promise in improving sleep quality in hospitalized and postoperative patient populations. Behavioral approaches such as relaxation techniques, stimulus control, and structured sleep hygiene have been associated with improvements in sleep duration and continuity. Pharmacologic alternatives, including zolpidem and melatonin, have demonstrated benefit in orthopedic and general adult populations by supporting sleep initiation, circadian regulation, and overall sleep quality.
This study builds on these findings through two complementary aims. Aim 1 analyzes previously collected actigraphy and survey data from a randomized controlled trial of adults with isolated orthopedic injuries (NCT04154384). In that study, participants wore wrist-worn actigraphy devices during hospitalization and completed validated sleep and pain assessments at baseline and postoperative follow-up visits. Preliminary analyses indicate that patients experience short, fragmented sleep and that higher opioid utilization may be associated with decreased sleep quantity and quality. Further analysis is needed to characterize these relationships using objective sleep metrics and detailed opioid timing and dosing data.
Aim 2 evaluates a multimodal sleep pathway designed to improve sleep quality and reduce opioid use during inpatient recovery. In a prospective randomized controlled trial, participants are assigned to receive either standard postoperative care or a sleep pathway that includes low-dose zolpidem, melatonin, and structured sleep hygiene education. The intervention begins on the first postoperative night and continues daily until discharge. Sleep outcomes are assessed using daily subjective questionnaires and continuous wrist actigraphy. Opioid consumption is recorded and converted to morphine milligram equivalents to allow standardized comparison. Pain perception is measured using validated patient-reported tools. Feasibility outcomes include recruitment, adherence to the intervention, actigraphy wear compliance, and retention through discharge. Safety monitoring includes assessment for medication-related side effects and actigraphy-related discomfort.
Together, these aims will provide foundational data on the relationship between opioid use and sleep quality in orthopedic trauma patients and will evaluate whether a structured multimodal sleep intervention can improve sleep and reduce reliance on opioids during hospitalization. Findings will inform the design of future larger-scale trials aimed at optimizing sleep and recovery in this population.
- Conditions
- Orthopedic Trauma, Sleep Quality
- Being tested
- Standard Postoperative Care, Zolpidem, Melatonin, Sleep Hygiene Education, Actigraph GT3X-BT Actigraph
- Keywords
- Multimodal Sleep Pathway, Sleep Quality, Opioid consumption
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Postoperative CareOther
Includes routine pain management and nursing care
ZolpidemDrug
- Dose: 5 mg
- Administration: Taken nightly at bedtime
- Purpose: Supports sleep initiation as part of the multimodal sleep pathway
- Additional Notes: FDA-approved sedative-hypnotic used short-term for insomnia
MelatoninDietary supplement
- Dose: 3 mg
- Administration: Taken 30 minutes before bedtime
- Purpose: Supports circadian regulation and sleep continuity
Sleep Hygiene EducationBehavioural
- Components: Guidance on consistent sleep schedules, minimizing nighttime disruptions, reducing screen exposure before bed, and optimizing environmental factors (light, noise, temperature)
- Delivery: Provided by research staff daily during hospitalization
Actigraph GT3X-BT ActigraphDevice
The ActiGraph GT3X-BT (ActiGraph, LLC; Pensacola, FL) is a lightweight, wrist-worn accelerometer used to objectively measure sleep-wake patterns in hospitalized patients. The device continuously records movement data that are processed using validated algorithms to estimate total sleep time, sleep efficiency, and number of awakenings.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Sleep Pathway | Experimental | 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. Receives: Drug: Zolpidem; Dietary Supplement: Melatonin; Behavioral: Sleep Hygiene Education; Device: Actigraph GT3X-BT Actigraph |
| Standard Care | Other | Participants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion. Receives: Other: Standard Postoperative Care; Device: Actigraph GT3X-BT Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
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.
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Sleep Efficiency
Percentage of time spent asleep while in bed, calculated from actigraphy data collected continuously during hospitalization.
Group comparisons will be conducted using independent t-tests or nonparametric equivalents. Mixed-effects modeling will assess within-subject changes over time and the effect of group assignment.
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Number of Awakenings
Total number of nighttime awakenings detected by actigraphy, reflecting sleep fragmentation.
Awakening counts will be compared between groups using Poisson or negative binomial regression models, depending on dispersion. Mixed-effects count models will evaluate changes over time.
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Subjective Sleep Quality: PROMIS scale
The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. Items are rated on 5-point Likert scales and summed to produce a raw score, which is converted to a standardized PROMIS T-score. Higher T-scores indicate greater sleep disturbance (worse sleep), and lower T-scores indicate less sleep disturbance (better sleep).
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)
The LSEQ is a 10-item patient-reported questionnaire that assesses subjective changes in sleep and early-morning functioning using 100-mm visual analogue scales. Items evaluate four domains: Getting to Sleep (GTS), Quality of Sleep (QOS), Awakening From Sleep (AFS), and Behavior Following Waking (BFW). Each item is scored from 0-100 mm, with higher scores indicating greater improvement relative to usual sleep and lower scores indicating worsening.
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Daily Opioid Utilization
Total opioid consumption recorded from the medical record and converted to morphine milligram equivalents (MMEs) to allow standardized comparison across medication types and dosing regimens.
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Secondary outcomes (7)
Pain Interference
Patient-reported pain interference with daily activities measured using a validated pain interference scale. Higher scores indicate greater interference
Measured: Daily during inpatient hospitalization (approximately 3-7 days)
Recruitment Feasibility
Assesses the proportion of eligible orthopedic trauma patients who enroll in the study during the inpatient recruitment window. Recruitment feasibility reflects the practicality of identifying, approaching, and enrolling participants in an acute trauma setting.
Recruitment rate will be calculated as the number of enrolled participants divided by the number of eligible patients approached. Results will be summarized using proportions and 95% confidence intervals.
Measured: Throughout the study (upto 7 days of hospital stay)
Adherence to Pharmacologic Components
Assesses adherence to the medication components of the multimodal sleep pathway, defined as the proportion of nights during which participants receive the prescribed low-dose zolpidem and melatonin as ordered.
Adherence will be summarized as the percentage of scheduled doses administered. Means, standard deviations, and proportions will be reported.
Measured: Throughout the study (upto 7 days of hospital stay)
Adherence to Non-Pharmacologic Components
Assesses adherence to daily sleep hygiene education, including completion of brief educational sessions delivered by research staff. Adherence reflects the feasibility of implementing behavioral components in a busy inpatient trauma environment.
Adherence will be summarized descriptively as the proportion of days on which sleep hygiene education was completed. Percentages and confidence intervals will be reported.
Measured: Throughout the study (upto 7 days of hospital stay)
Actigraphy Wear-Time Compliance
Assesses the proportion of hospitalization hours during which the ActiGraph GT3X-BT device records valid data. This measure assesses the feasibility and tolerability of continuous wrist-worn actigraphy in patients with orthopedic trauma.
Wear-time compliance will be calculated as the percentage of total hospitalization hours with valid actigraphy data. Descriptive statistics (means, SDs, ranges) will be reported.
Measured: Throughout the study (upto 7 days of hospital stay)
Retention Through Discharge
Assesses the proportion of enrolled participants who complete all study procedures through hospital discharge without withdrawal or protocol discontinuation.
Retention will be summarized as the percentage of participants completing the study through discharge. Proportions and 95% confidence intervals will be reported.
Measured: Throughout the study (upto 7 days of hospital stay)
Adverse Events Related to Study Interventions
Incidence of medication-related side effects (e.g., dizziness, drowsiness, complex sleep behaviors), melatonin intolerance, or actigraphy-related discomfort.
Adverse events will be summarized using frequencies and proportions. Between-group comparisons may use Fisher's exact test.
Measured: Throughout the study (upto 7 days of hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Jun 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic TraumaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- AO North America
- Responsible party
- Principal investigator, Mara Schenker, Emory University
- Investigators
- Mara Schenker, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336277
- Sponsor's protocol ID
- 2025P012693
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study team will share all non-protected data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT07336277
- Acronym / sponsor ID
- 2025P012693
- Conditions
- Orthopedic Trauma, Sleep Quality
- Keywords
- Multimodal Sleep Pathway, Sleep Quality, Opioid consumption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- AO North America
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Post-surgical orthopedic trauma patients frequently experience significant sleep disturbances, including reduced sleep quality, increased nighttime awakenings, and shortened sleep duration. Sleep and pain have a bidirectional relationship in which poor sleep increases pain sensitivity, and higher pain levels further disrupt sleep. Experimental sleep-restriction studies have shown that pain perception increases after only two nights of partial sleep deprivation and continues to worsen with each additional night. Despite these established interactions, objective sleep metrics have not been well characterized in the orthopedic trauma inpatient population, where postoperative pain, environmental disruptions, and medication use may all contribute to sleep disturbance.
Sleep patterns are also influenced by psychoactive substances, including opioids. Substance use and sleep-wake regulation share overlapping neurobiological pathways, and disruptions in circadian rhythms can occur during substance use, withdrawal, or detoxification. Although the mechanisms by which opioids alter sleep architecture are not fully understood, prior studies have shown that opioid exposure reduces restorative sleep stages, including deep sleep and rapid eye movement (REM) sleep, while increasing lighter stage-2 sleep. These changes may contribute to fragmented sleep and impaired recovery in postoperative patients who rely on opioids for pain management.
Non-opioid strategies have shown promise in improving sleep quality in hospitalized and postoperative patient populations. Behavioral approaches such as relaxation techniques, stimulus control, and structured sleep hygiene have been associated with improvements in sleep duration and continuity. Pharmacologic alternatives, including zolpidem and melatonin, have demonstrated benefit in orthopedic and general adult populations by supporting sleep initiation, circadian regulation, and overall sleep quality.
This study builds on these findings through two complementary aims. Aim 1 analyzes previously collected actigraphy and survey data from a randomized controlled trial of adults with isolated orthopedic injuries (NCT04154384). In that study, participants wore wrist-worn actigraphy devices during hospitalization and completed validated sleep and pain assessments at baseline and postoperative follow-up visits. Preliminary analyses indicate that patients experience short, fragmented sleep and that higher opioid utilization may be associated with decreased sleep quantity and quality. Further analysis is needed to characterize these relationships using objective sleep metrics and detailed opioid timing and dosing data.
Aim 2 evaluates a multimodal sleep pathway designed to improve sleep quality and reduce opioid use during inpatient recovery. In a prospective randomized controlled trial, participants are assigned to receive either standard postoperative care or a sleep pathway that includes low-dose zolpidem, melatonin, and structured sleep hygiene education. The intervention begins on the first postoperative night and continues daily until discharge. Sleep outcomes are assessed using daily subjective questionnaires and continuous wrist actigraphy. Opioid consumption is recorded and converted to morphine milligram equivalents to allow standardized comparison. Pain perception is measured using validated patient-reported tools. Feasibility outcomes include recruitment, adherence to the intervention, actigraphy wear compliance, and retention through discharge. Safety monitoring includes assessment for medication-related side effects and actigraphy-related discomfort.
Together, these aims will provide foundational data on the relationship between opioid use and sleep quality in orthopedic trauma patients and will evaluate whether a structured multimodal sleep intervention can improve sleep and reduce reliance on opioids during hospitalization. Findings will inform the design of future larger-scale trials aimed at optimizing sleep and recovery in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Sleep Pathway | Experimental | Drug: Zolpidem, Dietary Supplement: Melatonin, Behavioral: Sleep Hygiene Education, Device: Actigraph GT3X-BT ActigraphParticipants 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. |
| Standard Care | Other | Other: Standard Postoperative Care, Device: Actigraph GT3X-BT ActigraphParticipants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Postoperative CareIncludes routine pain management and nursing care | Other | Standard Care |
| Zolpidem* Dose: 5 mg * Administration: Taken nightly at bedtime * Purpose: Supports sleep initiation as part of the multimodal sleep pathway * Additional Notes: FDA-approved sedative-hypnotic used short-term for insomnia | Drug | Multimodal Sleep Pathway |
| Melatonin* Dose: 3 mg * Administration: Taken 30 minutes before bedtime * Purpose: Supports circadian regulation and sleep continuity | Dietary supplement | Multimodal Sleep Pathway |
| Sleep Hygiene Education* Components: Guidance on consistent sleep schedules, minimizing nighttime disruptions, reducing screen exposure before bed, and optimizing environmental factors (light, noise, temperature) * Delivery: Provided by research staff daily during hospitalization | Behavioural | Multimodal Sleep Pathway |
| Actigraph GT3X-BT ActigraphThe ActiGraph GT3X-BT (ActiGraph, LLC; Pensacola, FL) is a lightweight, wrist-worn accelerometer used to objectively measure sleep-wake patterns in hospitalized patients. The device continuously records movement data that are processed using validated algorithms to estimate total sleep time, sleep efficiency, and number of awakenings. | Device | Multimodal Sleep Pathway, Standard Care |
Primary outcome
Total Sleep Time
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
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.
Sleep Efficiency
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
Percentage of time spent asleep while in bed, calculated from actigraphy data collected continuously during hospitalization. Group comparisons will be conducted using independent t-tests or nonparametric equivalents. Mixed-effects modeling will assess within-subject changes over time and the effect of group assignment.
Number of Awakenings
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
Total number of nighttime awakenings detected by actigraphy, reflecting sleep fragmentation. Awakening counts will be compared between groups using Poisson or negative binomial regression models, depending on dispersion. Mixed-effects count models will evaluate changes over time.
Subjective Sleep Quality: PROMIS scale
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
The PROMIS Sleep Disturbance Short Form assesses self-reported perceptions of sleep quality, sleep depth, and restoration over the past 7 days. Items are rated on 5-point Likert scales and summed to produce a raw score, which is converted to a standardized PROMIS T-score. Higher T-scores indicate greater sleep disturbance (worse sleep), and lower T-scores indicate less sleep disturbance (better sleep).
Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
The LSEQ is a 10-item patient-reported questionnaire that assesses subjective changes in sleep and early-morning functioning using 100-mm visual analogue scales. Items evaluate four domains: Getting to Sleep (GTS), Quality of Sleep (QOS), Awakening From Sleep (AFS), and Behavior Following Waking (BFW). Each item is scored from 0-100 mm, with higher scores indicating greater improvement relative to usual sleep and lower scores indicating worsening.
Daily Opioid Utilization
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
Total opioid consumption recorded from the medical record and converted to morphine milligram equivalents (MMEs) to allow standardized comparison across medication types and dosing regimens.
7 secondary outcomes
Pain Interference
Time frame: Daily during inpatient hospitalization (approximately 3-7 days)
Recruitment Feasibility
Time frame: Throughout the study (upto 7 days of hospital stay)
Adherence to Pharmacologic Components
Time frame: Throughout the study (upto 7 days of hospital stay)
Adherence to Non-Pharmacologic Components
Time frame: Throughout the study (upto 7 days of hospital stay)
Actigraphy Wear-Time Compliance
Time frame: Throughout the study (upto 7 days of hospital stay)
Retention Through Discharge
Time frame: Throughout the study (upto 7 days of hospital stay)
Adverse Events Related to Study Interventions
Time frame: Throughout the study (upto 7 days of hospital stay)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. The study team will share all non-protected data upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tyler Edmond, MD contact
Mara Schenker, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Postoperative Care, Zolpidem and Melatonin in people with Orthopedic Trauma and Sleep Quality, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mara Schenker, MD (404-778-1550, mara.schenker@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: Daily during inpatient hospitalization (approximately 3-7 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.