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临床试验/NCT07336277
NCT07336277招募中3 期

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

Emory University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月2日最近更新:
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Total Sleep Time

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Standard Postoperative Care (Other)

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.

干预措施: Actigraph GT3X-BT Actigraph (Device)

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.

干预措施: Actigraph GT3X-BT Actigraph (Device)

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.

干预措施: Sleep Hygiene Education (Behavioral)

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.

干预措施: Zolpidem (Drug)

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.

干预措施: Melatonin (Dietary Supplement)

结局指标

主要结局

Total Sleep Time

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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).

Daily Opioid Utilization

时间窗: 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.

Subjective Sleep Quality: Leeds Sleep Evaluation Questionnaire (LSEQ)

时间窗: 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.

次要结局

  • Pain Interference(Daily during inpatient hospitalization (approximately 3-7 days))
  • Adherence to Pharmacologic Components(Throughout the study (upto 7 days of hospital stay))
  • Actigraphy Wear-Time Compliance(Throughout the study (upto 7 days of hospital stay))
  • Adherence to Non-Pharmacologic Components(Throughout the study (upto 7 days of hospital stay))
  • Recruitment Feasibility(Throughout the study (upto 7 days of hospital stay))
  • Retention Through Discharge(Throughout the study (upto 7 days of hospital stay))
  • Adverse Events Related to Study Interventions(Throughout the study (upto 7 days of hospital stay))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Schenker

Professor

Emory University

研究点 (1)

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