LaboristNCT02412410
Optimizing Sleep/Wake Related Cognitive Efficacy
A study testing Fatigue avoidance education in people with Laborist and Sleep, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive efficacy of laborists involved in shift work at Mayo Clinic Rochester. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Fatigue avoidance education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2018
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Physicians working in Laborist role, exclusion only by subject declining participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Optimizing Sleep/Wake Related Cognitive Efficacy in Laborist Shifts: Toward Establishing Models of Safer Obstetrical Care
This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive efficacy of laborists involved in shift work at Mayo Clinic Rochester.
Read the detailed description
Each of the ten physicians working laborist shifts will be asked to wear an actigraphy watch (ReadiBand- Fatigue Science, Vancouver, BC) continually for three weeks in the winter 2014-2015 for initial data collection. A brief sleep education intervention based on aerospace and military fatigue countermeasure training will be given at a one hour departmental grand rounds presentation on April 20, 2015. This intervention will be based on ACGME requirements for fatigue education for residents and will also address the latest data on sleep and health, as well as fatigue countermeasures of nap recommendations, sleep banking, and sleep hygiene. An additional two weeks of data will then be collected.
Data will be de-identified and entered into the Fatigue Science algorithm, which is validated to detect sleep quantity and quality. This algorithm allows labelling of data to reflect which type of shift, as well as its sequence in the schedule. For example, sleep/wake cycles of the fourth night shift of a series can be identified as such, so that wakefulness during a fourth night shift is not artificially compared to wakefulness during a first night of night shifts. Average efficacy during each type of shift, as well as average efficacy during each shift in a series of one type of shift can then be calculated. Efficacy is reported as a percentage, based on a nomogram established through military wakefulness task exercises and validated to correlate with blood alcohol level and with likelihood of human factor accident risk through the Department of Defense, US Army, US Navy, US Marine Corps, and Federal Railroad Association.
Calculated data on shift efficacy will significantly contribute to the growing literature on the strengths of the laborist model, and will help with internal schedule structure to continue to maximize efficacy. As laborist programs develop and expand, the investigators may also be forerunners in describing optimal scheduling and staffing for programs of similar size and scope. Ultimately, additional studies will use this innovative technology to elucidate the assumed but not scientifically established relationship between sleep/wake based cognitive efficacy and patient safety by superimposing the investigators' wakefulness data on the investigators' tracked adverse events. This would be landmark in the investigators' field and has the potential to effect groundbreaking safety measures in the investigators' training and staffing.
- Being tested
- Fatigue avoidance education
- Keywords
- laborist, efficacy, sleep, fatigue, SAFTE, cognition
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue avoidance educationBehavioural
Grand Rounds presentation of consequences of fatigue and fatigue avoidance techniques
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Single arm pilot study analyzing sleep data and calculated efficacy before and after fatigue avoidance education (comparator is same group after intervention) Receives: Behavioral: Fatigue avoidance education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education
Comparison of calculated efficacy scores before and after fatigue avoidance education
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaboristStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret L. Dow, M.D., Mayo Clinic
- Investigators
- Margaret Dow, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412410
- Sponsor's protocol ID
- 14-008496
- Status last verified
- Feb 2018
- First submitted
- 6 Apr 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Sleep/Wake Related Cognitive Efficacy in Laborist Shifts: Toward Establishing Models of Safer Obstetrical Care
- ClinicalTrials.gov ID
- NCT02412410
- Acronym / sponsor ID
- 14-008496
- Keywords
- laborist, efficacy, sleep, fatigue, SAFTE, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 9 Apr 2015 (estimated)
- 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.
This is a pilot study designed to elucidate sleep/wake patterns and associated cognitive efficacy of laborists involved in shift work at Mayo Clinic Rochester.
Detailed description
Each of the ten physicians working laborist shifts will be asked to wear an actigraphy watch (ReadiBand- Fatigue Science, Vancouver, BC) continually for three weeks in the winter 2014-2015 for initial data collection. A brief sleep education intervention based on aerospace and military fatigue countermeasure training will be given at a one hour departmental grand rounds presentation on April 20, 2015. This intervention will be based on ACGME requirements for fatigue education for residents and will also address the latest data on sleep and health, as well as fatigue countermeasures of nap recommendations, sleep banking, and sleep hygiene. An additional two weeks of data will then be collected.
Data will be de-identified and entered into the Fatigue Science algorithm, which is validated to detect sleep quantity and quality. This algorithm allows labelling of data to reflect which type of shift, as well as its sequence in the schedule. For example, sleep/wake cycles of the fourth night shift of a series can be identified as such, so that wakefulness during a fourth night shift is not artificially compared to wakefulness during a first night of night shifts. Average efficacy during each type of shift, as well as average efficacy during each shift in a series of one type of shift can then be calculated. Efficacy is reported as a percentage, based on a nomogram established through military wakefulness task exercises and validated to correlate with blood alcohol level and with likelihood of human factor accident risk through the Department of Defense, US Army, US Navy, US Marine Corps, and Federal Railroad Association.
Calculated data on shift efficacy will significantly contribute to the growing literature on the strengths of the laborist model, and will help with internal schedule structure to continue to maximize efficacy. As laborist programs develop and expand, the investigators may also be forerunners in describing optimal scheduling and staffing for programs of similar size and scope. Ultimately, additional studies will use this innovative technology to elucidate the assumed but not scientifically established relationship between sleep/wake based cognitive efficacy and patient safety by superimposing the investigators' wakefulness data on the investigators' tracked adverse events. This would be landmark in the investigators' field and has the potential to effect groundbreaking safety measures in the investigators' training and staffing.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Behavioral: Fatigue avoidance educationSingle arm pilot study analyzing sleep data and calculated efficacy before and after fatigue avoidance education (comparator is same group after intervention) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fatigue avoidance educationGrand Rounds presentation of consequences of fatigue and fatigue avoidance techniques | Behavioural | Single |
Primary outcome
Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education
Time frame: 3 months
Comparison of calculated efficacy scores before and after fatigue avoidance education
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
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.
Margaret Dow, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue avoidance education in people with Laborist and Sleep, run by Mayo Clinic 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?
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: finished, as of the sponsor's last update on 22 Feb 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optimizing efficacy through fatigue avoidance -Comparison of calculated efficacy scores before and after fatigue avoidance education (time frame: 3 months). 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 22 Feb 2018.