FatigueNCT06100809
Does Fatigue Coaching Improve Functioning and Fatigue in Resident Night Shifts
A study testing Personalized coaching and Nutrition handout in people with Fatigue and Shift Work Type Circadian Rhythm Sleep Disorder, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Shift Work Type Circadian Rhythm Sleep Disorder
- What is being tested?
- Personalized coaching and Nutrition handout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- emergency medicine resident
- scheduled to work at least 4 overnight consecutive shifts
Who cannot join
- not willing to wear Fitbit device during the study
- not willing to answer questionnaires
- not willing to receive text messages during the study
- not willing to meet with a lifestyle coach during the study
- not willing t0 download app to their personal smartphone or residency-supplied smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
UMassMemorial Health Care
Worcester, Massachusetts, 01655-0002
About this study
Official title: Personalized Fatigue-Mitigation Lifestyle Coaching (PFMLC) to Improve Performance and Recovery Among Emergency Medicine Residents on Night Shifts
Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.
Read the detailed description
The investigators will use a block-randomized design utilizing each 28-day scheduling period as a block.
Baseline characteristics and confounding factors such as gender, habitual diet, sleep, and caffeine intake will be collected on the first night of the study. Outcome measures will be assessed at the beginning of the shift and between the hours of 2:00 AM to 5:00 AM when sleep propensity and decreased alertness peak.
Outcome measures include a) Stanford Sleepiness Scale (SSS): which takes about 15 seconds to complete. b) Work Exhaustion (4 questions overall): take 20 seconds to complete. c) electronic psychomotor vigilance test: take 3 minutes to complete. The psychomotor vigilance test is a gamified method to measure both vigilance and reaction time. Done on a phone, a colored block appears on the screen, and when a participant sees the block, the participant taps the screen. Reaction time is measured in milliseconds and the average reaction time over the 3 minutes is calculated by the program and reported to the participant as well as stored in the participant's profile.
Study participants will be required to participate in the study for a total of 18 days. Each study participant will contribute biometric data for 7 days before a string of at least 4 consecutive night shifts, then for another 7 days (for a total of 18 days). A self-care handout containing nutrition tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. A Fitbit device will be provided to all participants to measure biometrics data.
Control: The investigators will not provide personalized coaching and ask the control participants to follow and record their typical nightshift habits. The control participants will participate in the surveys and tests as above. Control participants will receive a daily text message to remind them to do the surveys and tests during their shifts. The investigators will instruct the control participants to make sure their phones are silenced during this time as part of better habits for sleep.
- Being tested
- Personalized coaching, Nutrition handout
- Keywords
- Fatigue, Shift Work
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized coachingBehavioural
Personalized fatigue mitigation coaching.
Nutrition handoutBehavioural
Nutrition handout
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | No coaching provided. Nutrional handout only Receives: Behavioral: Nutrition handout |
| Intervention | Experimental | Coaching provided. Nutrition handout also provided Receives: Behavioral: Personalized coaching; Behavioral: Nutrition handout |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of mean reaction time reciprocal (lower is desirable).
Measured: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Mean of the change in 3 overnight percentage changes (from pre-shift) in number of lapses in PVT
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of number of lapses (lower is desirable).
Measured: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Mean of the change in 3 overnight percentage changes (from pre-shift) in aggregrate PVT score
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts.
The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of aggregate score (0 worst - 100 best).
Measured: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Mean of the change in 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete.
Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable.
The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups.
Measured: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Mean of the change 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE) Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:
Global well-being: Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better This test takes approximately 90 seconds to complete.We will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups
Measured: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Secondary outcomes (2)
Mean of total hours of sleep
Total sleep hours per 24-hour period during a baseline week, the period of night shifts, and a recovery week using FitBit Versa 4, between the two groups will be compared.
Measured: 1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts
Mean of heart rate variability
Heart rate variability per 24-hour period during a baseline week, the period of night shifts, and a recovery week using Fitbit Versa 4, between the two groups will be compared.
Measured: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Why it stopped: Change of personnel and insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Bird, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100809
- Sponsor's protocol ID
- 00000500
- Status last verified
- Sep 2026
- First submitted
- 10 May 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Fatigue-Mitigation Lifestyle Coaching (PFMLC) to Improve Performance and Recovery Among Emergency Medicine Residents on Night Shifts
- ClinicalTrials.gov ID
- NCT06100809
- Acronym / sponsor ID
- 00000500
- Keywords
- Fatigue, Shift Work
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of personnel and insufficient funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 25 Oct 2023 (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.
Emergency Medicine (EM) requires 24/7 staff coverage resulting in healthcare workers' circadian rhythm disruptions that impair clinical and cognitive performance, physical recovery, and contribute to burnout. Multiple well-being surveys continue to highlight EM's challenges with sleep impairment due to the nature of the specialty. Despite evidence that lifestyle strategies effectively optimize performance and recovery, EM residents have variable lifestyle choices to prepare for overnight shifts. This prospective randomized controlled trial will examine whether a pre-shift personalized fatigue-mitigation lifestyle coaching (PFMLC) for EM residents on overnight shifts minimizes the effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices. All participants will receive lifestyle strategy materials on fatigue mitigation to improve performance. Residents' self-reported and biometric data will inform PFMLC in the active arm. Performance and recovery from night shifts will be assessed by changes in sleep, heart rate variability, readiness/recovery, alertness, cognitive performance, and mental health using Fitbit and validated measures.
Detailed description
The investigators will use a block-randomized design utilizing each 28-day scheduling period as a block.
Baseline characteristics and confounding factors such as gender, habitual diet, sleep, and caffeine intake will be collected on the first night of the study. Outcome measures will be assessed at the beginning of the shift and between the hours of 2:00 AM to 5:00 AM when sleep propensity and decreased alertness peak.
Outcome measures include a) Stanford Sleepiness Scale (SSS): which takes about 15 seconds to complete. b) Work Exhaustion (4 questions overall): take 20 seconds to complete. c) electronic psychomotor vigilance test: take 3 minutes to complete. The psychomotor vigilance test is a gamified method to measure both vigilance and reaction time. Done on a phone, a colored block appears on the screen, and when a participant sees the block, the participant taps the screen. Reaction time is measured in milliseconds and the average reaction time over the 3 minutes is calculated by the program and reported to the participant as well as stored in the participant's profile.
Study participants will be required to participate in the study for a total of 18 days. Each study participant will contribute biometric data for 7 days before a string of at least 4 consecutive night shifts, then for another 7 days (for a total of 18 days). A self-care handout containing nutrition tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. A Fitbit device will be provided to all participants to measure biometrics data.
Control: The investigators will not provide personalized coaching and ask the control participants to follow and record their typical nightshift habits. The control participants will participate in the surveys and tests as above. Control participants will receive a daily text message to remind them to do the surveys and tests during their shifts. The investigators will instruct the control participants to make sure their phones are silenced during this time as part of better habits for sleep.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Nutrition handoutNo coaching provided. Nutrional handout only |
| Intervention | Experimental | Behavioral: Personalized coaching, Behavioral: Nutrition handoutCoaching provided. Nutrition handout also provided |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- emergency medicine resident
- scheduled to work at least 4 overnight consecutive shifts
Key exclusion criteria (5 listed)
- not willing to wear Fitbit device during the study
- not willing to answer questionnaires
- not willing to receive text messages during the study
- not willing to meet with a lifestyle coach during the study
- not willing t0 download app to their personal smartphone or residency-supplied smartphone
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 |
|---|---|---|
| Personalized coachingPersonalized fatigue mitigation coaching. | Behavioural | Intervention |
| Nutrition handoutNutrition handout | Behavioural | Control, Intervention |
Primary outcome
Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time
Time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of mean reaction time reciprocal (lower is desirable).
Mean of the change in 3 overnight percentage changes (from pre-shift) in number of lapses in PVT
Time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of number of lapses (lower is desirable).
Mean of the change in 3 overnight percentage changes (from pre-shift) in aggregrate PVT score
Time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups for the PVT outcome of aggregate score (0 worst - 100 best).
Mean of the change in 3 overnight percentage changes (from pre-shift) in Stanford Sleepiness Scale
Time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete. Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable. The investigators will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups.
Mean of the change 3 overnight percentage changes (from pre-shift) in Noordsy-Dahle Subjective Experience Scale (NDSE) Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains:
Time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]
Global well-being: Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better This test takes approximately 90 seconds to complete.We will compare the mean of the 3 overnight percentage changes from pre to mid-shift between the control and intervention groups
2 secondary outcomes
Mean of total hours of sleep
Time frame: 1 week of baseline, during the 1 week of night shifts, and for 1 week after the night shifts
Mean of heart rate variability
Time frame: 1 week of baseline, during the week of night shifts, and for 1 week after the night shifts
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized coaching and Nutrition handout in people with Fatigue and Shift Work Type Circadian Rhythm Sleep Disorder, run by University of Massachusetts, Worcester 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 23 Oct 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of the change in 3 overnight percentage changes (from pre-shift) in mean reaction time (time frame: Two time points (beginning and middle of night shifts) on each night for a total of 3 nights]). The study lists 5 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 23 Oct 2026.