Recruiting
Phase 3

Multimodal Sleep Pathway

Sponsor:

Emory University

Code:

NCT07336277

Conditions

Orthopedic Trauma

Sleep Quality

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Standard Postoperative Care

Zolpidem

Melatonin

Sleep Hygiene Education

Actigraph GT3X-BT Actigraph

Study Details

Brief 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

Conditions

Orthopedic Trauma

Sleep Quality

Study ID

NCT07336277

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Multimodal Sleep Pathway

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.

other: Standard Care

Participants receive routine postoperative care without sleep-specific pharmacologic or behavioral interventions. Standard pain management is provided per the clinical team's discretion.

Interventions

Standard Postoperative Care

Includes routine pain management and nursing 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

Melatonin

  • Dose: 3 mg
  • Administration: Taken 30 minutes before bedtime
  • Purpose: Supports circadian regulation and sleep continuity

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

Actigraph GT3X-BT Actigraph

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.

Primary outcome measure

  • Total Sleep Time [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]
  • Sleep Efficiency [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]
  • Number of Awakenings [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]
  • Subjective Sleep Quality: PROMIS scale [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]
  • Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]
  • Daily Opioid Utilization [ Time Frame: Daily during inpatient hospitalization (approximately 3-7 days) ]

Central Contacts and Locations

Central contacts

Mara Schenker, MD

404-778-1550mara.schenker@emory.edu

Tyler Edmond, MD

tjedmon@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30324

Contacts

Mara Schenker, MD

404-778-1550mara.schenker@emory.edu

Tyler Edmond, MD

tjedmon@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Multimodal Sleep Pathway
  • Sleep Quality
  • Opioid consumption

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-30.