- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666633
Non-Invasive Sleep Monitoring for Burnout and Retention Risk in Postgraduate Nurses
Development of a Non-Invasive Sleep-Based Prediction Platform for Burnout and Retention Risk Among Postgraduate Nurses: A Psychophysiological and AI-Driven Approach for High-Stress Clinical Populations
Newly graduated nurses often experience high levels of psychological stress, sleep disturbance, fatigue, and burnout during the early transition into clinical practice. Early identification of burnout and retention risk may help improve mental well-being, workforce stability, and quality of patient care.
This longitudinal observational study aims to develop a non-invasive sleep-based prediction platform for assessing burnout and retention risk among postgraduate nurses. Participants will undergo repeated psychological assessments and non-contact sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be collected together with validated psychological questionnaires.
The study will further apply machine learning and artificial intelligence approaches to integrate longitudinal physiological and psychological data for risk prediction and early identification of burnout-related conditions. The findings may support future development of precision mental health monitoring and supportive management strategies for high-stress healthcare workers.
Study Overview
Status
Intervention / Treatment
Detailed Description
Postgraduate nurses frequently experience substantial psychological and physiological stress during the transition from academic training to clinical practice. Heavy workloads, rotating shifts, emotional demands, and adaptation to clinical environments may contribute to sleep disturbance, fatigue, burnout, and increased turnover intention. Previous studies have demonstrated significant associations between sleep quality, autonomic nervous system regulation, emotional distress, and occupational burnout among healthcare workers, particularly in shift-working nurses.
Current psychological assessments mainly rely on self-reported questionnaires and short-term evaluations, which may not adequately capture dynamic physiological changes over time. Recent advances in non-contact sleep monitoring technologies provide opportunities for continuous and low-burden collection of sleep-related physiological data in natural sleep environments. In addition, artificial intelligence and machine learning approaches may improve early identification of individuals at higher risk of burnout and retention problems.
This study is a prospective longitudinal observational study designed to investigate the relationship between sleep-related physiological characteristics, psychological status, burnout risk, and retention risk among postgraduate nurses during the early clinical transition period.
Eligible participants will include newly employed postgraduate nurses within three months of clinical employment. Participants will complete validated psychological questionnaires, including the Brief Symptom Rating Scale-5 (BSRS-5), Chinese Health Questionnaire-12 (CHQ-12), Pittsburgh Sleep Quality Index (PSQI), Karolinska Sleepiness Scale (KSS), and Copenhagen Burnout Inventory (CBI). In parallel, participants will undergo non-invasive and non-contact sleep monitoring under natural sleep conditions. Sleep-related physiological parameters including sleep efficiency, sleep stage distribution, deep sleep proportion, REM sleep stability, heart rate variability, and respiratory variability will be analyzed.
Repeated assessments will be conducted longitudinally at baseline, 3 months, and 6 months. Statistical analyses will include descriptive statistics, longitudinal analyses, generalized estimating equations, mixed-effects models, and survival-related analyses when applicable. Machine learning and deep learning approaches, including Random Forest, XGBoost, and longitudinal prediction models, will be applied to develop predictive models for burnout and retention risk.
The study does not involve therapeutic intervention, medication administration, or changes to work schedules. All collected data will be de-identified and managed according to institutional research ethics and privacy protection regulations. The results of this study may contribute to the future development of precision mental health monitoring systems and supportive management strategies for high-stress healthcare professionals.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chih-Hsuan Chang, MS
- Phone Number: +886905163699
- Email: abstyle0204@gmail.com
Study Contact Backup
- Name: Yung-Kuo Lee, PhD
- Phone Number: +886910977485
- Email: yungkuolee@gmail.com
Study Locations
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Kaohsiung City
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Kaohsiung City, Kaohsiung City, Taiwan, 80284
- Kaohsiung Armed Forces General Hospital
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Contact:
- Chih-Hsuan Chang, MS
- Phone Number: +886905163699
- Email: abstyle0204@gmail.com
-
Contact:
- Yung-Kuo Lee, PhD
- Phone Number: +886910977485
- Email: yungkuolee@gmail.com
-
Principal Investigator:
- Hui-Ru Lin, MS
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly employed postgraduate nurses within the first 3 months of clinical practice
- Age 20 to 65 years
- Full-time clinical nursing staff
- Able to read and complete Chinese questionnaires
- Willing to participate in repeated psychological assessments and non-invasive sleep monitoring
- Able to provide written informed consent
Exclusion Criteria:
- Diagnosed severe sleep disorders
- Diagnosed severe psychiatric disorders
- Current use of medications that significantly affect sleep or autonomic nervous system function
- Inability to comply with longitudinal follow-up procedures
- Inability to complete repeated sleep monitoring assessments
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Postgraduate Nurses (PGNs)
Newly employed postgraduate nurses within the first three months of clinical practice will be enrolled and followed longitudinally.
Participants will complete repeated psychological assessments and undergo non-invasive sleep monitoring during the study period.
Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be analyzed to evaluate burnout risk, psychological stress, fatigue, and retention risk during the early clinical transition period.
|
Participants will undergo non-invasive and non-contact sleep monitoring under natural sleep conditions.
The monitoring system will collect sleep-related physiological signals and estimate sleep parameters, including sleep efficiency, sleep stage distribution, deep sleep proportion, REM sleep stability, heart rate variability, and respiratory variability.
This procedure is used for observational data collection only and does not involve treatment or changes to clinical work schedules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Copenhagen Burnout Inventory (CBI) Score
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of burnout severity using the Copenhagen Burnout Inventory (CBI), a validated questionnaire for evaluating personal and work-related burnout symptoms.
The CBI score ranges from 0 to 100, with higher scores indicating greater burnout severity.
|
Baseline, 3 months, and 6 months
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire for evaluating subjective sleep quality and sleep disturbance.
The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
|
Baseline, 3 months, and 6 months
|
|
Brief Symptom Rating Scale-5 (BSRS-5) Score
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of psychological distress using the Brief Symptom Rating Scale-5 (BSRS-5), a validated questionnaire for evaluating anxiety, depression, hostility, interpersonal sensitivity, and insomnia symptoms.
The BSRS-5 total score ranges from 0 to 20, with higher scores indicating greater psychological distress.
|
Baseline, 3 months, and 6 months
|
|
Chinese Health Questionnaire-12 (CHQ-12) Score
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of mental health status using the Chinese Health Questionnaire-12 (CHQ-12), a validated questionnaire for evaluating psychological well-being and minor psychiatric morbidity.
Higher scores indicate poorer mental health status.
|
Baseline, 3 months, and 6 months
|
|
Karolinska Sleepiness Scale (KSS) Score
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of subjective sleepiness using the Karolinska Sleepiness Scale (KSS).
The KSS score ranges from 1 to 9, with higher scores indicating greater subjective sleepiness.
|
Baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Efficiency
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of sleep efficiency derived from non-invasive sleep monitoring.
Higher values indicate better sleep efficiency.
|
Baseline, 3 months, and 6 months
|
|
Deep Sleep Proportion
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of deep sleep proportion derived from non-invasive sleep monitoring.
Higher values indicate a greater proportion of deep sleep during total sleep time.
|
Baseline, 3 months, and 6 months
|
|
REM Sleep Stability
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of REM sleep stability derived from non-invasive sleep monitoring.
|
Baseline, 3 months, and 6 months
|
|
Heart Rate Variability
Time Frame: Baseline, 3 months, and 6 months
|
Assessment of autonomic nervous system regulation using heart rate variability derived from non-invasive sleep monitoring.
|
Baseline, 3 months, and 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yung-Kuo Lee, PhD, Kaohsiung Armed Forces General Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Behavioral Symptoms
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Occupational Diseases
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Personal Satisfaction
- Burnout, Psychological
- Occupational Stress
- Parasomnias
- Fatigue
- Sleep Initiation and Maintenance Disorders
- Stress, Psychological
- Psychological Well-Being
Other Study ID Numbers
- KAFGHIRB 115-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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