Shift-Work Sleep DisorderNCT03813654
Sleep and Circadian Treatments for Shift Workers
A study testing 8-h Afternoon-Evening Sleep and 8-h Free Sleep in people with Shift-Work Sleep Disorder and Shift-Work Related Sleep Disturbance, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
There are three components to this study: a Field Trial, a Shift Worker Survey, and Focus Groups. The Investigators will study the effectiveness, feasibility, and acceptability of an 8-h sleep intervention in older night workers in an operational environment. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder, Shift-Work Related Sleep Disturbance
- What is being tested?
- 8-h Afternoon-Evening Sleep and 8-h Free Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-65 years
- Health care workers who work a minimum of 4 night shifts (8-4) per month
- Must live in the greater Boston area
- Must report an ability to work three successive 8-h night shifts during two weeks
- Must report an ability to spend 8 consecutive hours in bed attempting to sleep prior to the final two successive night shifts in the second study week
- Must have a typical commute time between home and place of work of less than one hour
Who cannot join
- Non-optional activities that would interfere with the participant's ability to remain in bed attempting to sleep if randomized to an 8-h sleep group
- Prescription or over-the-counter medication(s) known to affect sleep [e.g., hypnotics] or alertness [e.g., antihistamines]
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
There are three components to this study: a Field Trial, a Shift Worker Survey, and Focus Groups. The Investigators will study the effectiveness, feasibility, and acceptability of an 8-h sleep intervention in older night workers in an operational environment. The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that, including sleepiness and performance impairments during night shift work. The Shift Worker Survey is designed to understand some of the demographic and operational factors that enable or inhibit the ability of individual shift workers to adopt this intervention. The Focus Groups are designed to glean in-depth information from older shift workers who indicate that they are unable or unwilling to adopt an 8-h sleep timing intervention. Understanding these factors will assist in refining and targeting the intervention to those individuals who will be most likely to benefit from the intervention sleep timing strategy.
Read the detailed description
The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that, including sleepiness and performance impairments during night shift work. The experimental protocol is divided into two blocks, the Baseline block and the Intervention block, where participants will work at least 3 night shifts in a row within each block. For at least one week prior to the baseline block participants will work their usual shift schedule (i.e., no vacation/scheduled days off). The investigators will recruit up to 200 health care workers in order to have up to 75 health care workers complete the entire Field Trial. Potential participants will be employed older health care workers who work a minimum number of 8-h night shifts per month and who are in the greater Boston area.
The Shift Worker Survey is designed to understand some of the demographic and operational factors that enable or inhibit the ability of individual shift workers to adopt the sleep intervention that will be tested in the Field Trial. The investigators will use a web-based survey consisting of ~70 questions developed and administered using REDCap. The complete questionnaire will take approximately 20-30 minutes to complete. The study will enroll up to 1,000 employed individuals (20 or more hours per week) whose work includes overnight shifts, with a minimum criterion of at least 4 night shifts a month. Health Care Workers who complete the Shift Worker Survey will be given the option to complete an additional Health Care Worker's Questionnaire at the end of the basic Shift Worker Survey. Those whose responses meet inclusion/exclusion criteria for the Field Trial will be informed at the end of the Shift Worker Survey that they may be eligible for the Field Trial.
The goal of the Focus Groups is to gain information on the feasibility and acceptability of the fixed 8-h sleep schedule from the participants' perspective. Investigators will seek to learn more information about the current sleep strategies they use on a regular basis, and both the facilitating and challenging aspects of the fixed-sleep countermeasure (e.g., individual, intrapersonal and organizational barriers to implementation of fixed 8-h sleep, recommended modifications to the fixed 8-h sleep schedule that would make it more user-friendly while maintaining scientific validity). Each of the focus groups will consist of 4-6 individuals to stimulate discussion without leaving participants out, and will last 60-90 minutes. The investigators aim to enroll up to 60 individuals in Focus Groups. In addition to the health care workers who took part in the Field Trial, the investigators will invite night shift workers who complete the Shift Worker Survey but indicate their inability to comply with a fixed 8-h sleep schedule to attend a Focus Group discussion.
- Being tested
- 8-h Afternoon-Evening Sleep, 8-h Free Sleep
- Keywords
- sleep, attention, vigilance, aging, shift work
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-h Afternoon-Evening SleepBehavioural
8 consecutive hours time in bed during the afternoon/evening.
8-h Free SleepBehavioural
8 consecutive hours time in bed at any time.
| Study group | Role | What they receive |
|---|---|---|
| Control (Group A) | No intervention | During the intervention block of the Field Trial, at the end of the first night shift, the participant will be told about their randomization group. In the control group (Group A), participants will not be given any instructions about the timing or duration of their sleep, but will be instructed to follow their usual night shift sleep routine. |
| 8-h Afternoon-Evening Sleep (Group B) | Experimental | In the 8-h afternoon-evening sleep intervention group (Group B), participants will be instructed to go to bed between 13:00 and 14:00 (depending on their individual commute time) and to remain in bed attempting to sleep for 8 hours (until 21:00-22:00) before the next two night shifts. Receives: Behavioral: 8-h Afternoon-Evening Sleep |
| 8-h Free Sleep (Group C) | Experimental | In the 8-h free sleep group (Group C), participants will be instructed to remain in bed for 8 continuous hours before the next two night shifts, but will not be given any instruction regarding which 8 hours they should sleep. Receives: Behavioral: 8-h Free Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time (TST)
TST is calculated as minutes of sleep in the main sleep episode between shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep. For control group participants who will sleep ad-lib, TST will be calculated for the major sleep episode but also will be summed across sleep episodes if they sleep in more than one bout.
Measured: The TST averaged for up to 3 intervention nights (in minutes) will be compared between groups.
Sleep Fragmentation Index (FI)
FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.
Measured: The FI averaged for intervention nights 2 and 3 will be compared between groups.
Wake After Sleep Onset (WASO)
WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.
Measured: The WASO averaged for intervention nights 2 and 3 will be compared between groups.
Subjective Sleep Quality
Participants will report their subjective sleep quality daily upon awakening from the main sleep episode. Multiple measures of subjective sleep quality will be assessed, but the investigators will report how refreshed the participant feels after awakening as the outcome. This is rated on a 7-point scale, where 7 is the best and 1 is the worst.
Measured: Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.
Subjective Alertness Via Karolinska Sleepiness Scale (KSS)
Participants will complete the Karolinska Sleepiness Scale (KSS) as a measure of subjective alertness immediately following each night shift. The KSS is a Likert scale ranging from 1, extremely alert, to 9, extremely sleepy.
Measured: The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared to that at baseline.
Sustained Attention
The psychomotor vigilance task (PVT) is a test of visual reaction time (RT) in which the participant is asked to maintain the fastest possible RTs to a simple visual stimulus for several minutes. The inter-stimulus interval varies randomly between 2-10 seconds. While there are a number of standard performance metrics that can be obtained from each PVT, we have looked at the slowest 10% of responses.
Measured: PVT mean of slowest 10% of responses measured at the start of the final night shift (night shift 3) during the intervention block will be compared between groups.
Subjective Energy
A Visual Analogue Scale (VAS) will be used to assess subjective energy level. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. energetic-sluggish. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as subjective energeticness. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective energy.
Measured: Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Stress Via Visual Analog Scale (VAS)
A Visual Analogue Scale (VAS) will be used to assess subjective stress.The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. relaxed-stressed. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Stress. Thus, scores on the scale range from 0 to 100 with higher scores indicating greater subjective stress.
Measured: Subjective Stress via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Calmness Via Visual Analog Scale (VAS)
A Visual Analogue Scale (VAS) will be used to assess subjective Calmness. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. calm-excited. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Calmness. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective calmness.
Measured: Subjective Calmness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Health Via Visual Analog Scale (VAS)
Visual Analogue Scales (VAS) will be used to assess subjective health. VAS consist of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. healthy-sick. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Health. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective health.
Measured: Subjective Health via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Subjective Alertness Via Visual Analog Scale (VAS) - DATA NOT COLLECTED
Participants will complete the Visual Analog Scale (VAS) as a measure of subjective alertness three times per night shift: Once just before the night shift, once during their shift break, and once immediately following the night shift. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. sleepy-alert. Participants will indicate a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Alertness with higher scores indicating greater subjective alertness.
Measured: Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Secondary outcomes (4)
Fatigue and Inter-Shift Recovery
The Occupational Fatigue Exhaustion Recovery Scale (OFER 15), which consists of 15 questions about acute fatigue and recovery between shifts, will be used. Each of the 15 questions is answered on a Likert scale which ranges from 0 (Strongly Disagree) to 6 (Strongly Agree). The OFER15 will be completed immediately after the third night shift in the Baseline block and at the end of the third night shift in the Intervention block.
Measured: OFER15 scores from the end of the third night shift in the Baseline to the end of the Intervention block will be compared between groups.
Subjective Stress
The investigators will collect subjective measures of daily stress using a validated questionnaire, the Perceived Stress Scale (PSS), a 10-item self-report measure that allows a person to indicate stressful events that they have experienced in the past week. Each question is answered on a 5-item scale indicating the frequency, from 1 (never) to 5 (very often).
Measured: Subjective stress will be assessed immediately after the third night shift in the Baseline and Intervention blocks and the change will be compared between groups.
Subjective Quality of Life: WHOQOLBref
The investigators will use a validated questionnaire, the WHOQOLBref, a 26 item questionnaire suitable for field studies, which asks a series of questions about life, health, energy, and personal satisfaction, to assess Quality of Life. The questionnaire contains 4 separately scored domains: Physical Health, Psychological, Social Relationships, and Environment. Each domain contains several questions and ask participants to provide a response on a Likert Scale ranging from 1 to 5, with higher numbers indicating a higher quality of life (aside from 3 negatively phrased items).
Measured: WHOQOL-Bref will be taken at Baseline and immediately after the third night shift in the Intervention block and will be compared between groups.
Salivary Cortisol Level NOTE THAT THIS AIM WAS DROPPED WHEN THE STUDY WENT TO FULLY REMOTE DUE TO COVID
The investigators will collect a single saliva sample at the end of the final night shift in the Baseline block and the Intervention block. The sample will be frozen and later assayed to assess cortisol level (in micrograms per deciliter, μg/dL). Higher cortisol levels will be indicative of greater stress.
Measured: Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start20 Aug 2020
- Primary completion1 Oct 2023
- Study completion31 Dec 2023
Why it stopped: Funding for project ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study design describes the Field Trial only.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Massachusetts, Lowell
- Responsible party
- Principal investigator, Jeanne Duffy, Brigham and Women's Hospital
- Investigators
- Jeanne F Duffy, MBA, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813654
- Sponsor's protocol ID
- 2018-P-002341
- Other IDs
- R01AG044416
- Status last verified
- Jul 2025
- First submitted
- 8 Jan 2019
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Circadian Treatments for Shift Workers
- ClinicalTrials.gov ID
- NCT03813654
- Acronym / sponsor ID
- 2018-P-002341
- Keywords
- sleep, attention, vigilance, aging, shift work
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding for project ended
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Massachusetts, Lowell
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are three components to this study: a Field Trial, a Shift Worker Survey, and Focus Groups. The Investigators will study the effectiveness, feasibility, and acceptability of an 8-h sleep intervention in older night workers in an operational environment. The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that, including sleepiness and performance impairments during night shift work. The Shift Worker Survey is designed to understand some of the demographic and operational factors that enable or inhibit the ability of individual shift workers to adopt this intervention. The Focus Groups are designed to glean in-depth information from older shift workers who indicate that they are unable or unwilling to adopt an 8-h sleep timing intervention. Understanding these factors will assist in refining and targeting the intervention to those individuals who will be most likely to benefit from the intervention sleep timing strategy.
Detailed description
The overall goal of the Field Trial is to minimize sleep deficiency and negative outcomes resulting from that, including sleepiness and performance impairments during night shift work. The experimental protocol is divided into two blocks, the Baseline block and the Intervention block, where participants will work at least 3 night shifts in a row within each block. For at least one week prior to the baseline block participants will work their usual shift schedule (i.e., no vacation/scheduled days off). The investigators will recruit up to 200 health care workers in order to have up to 75 health care workers complete the entire Field Trial. Potential participants will be employed older health care workers who work a minimum number of 8-h night shifts per month and who are in the greater Boston area.
The Shift Worker Survey is designed to understand some of the demographic and operational factors that enable or inhibit the ability of individual shift workers to adopt the sleep intervention that will be tested in the Field Trial. The investigators will use a web-based survey consisting of ~70 questions developed and administered using REDCap. The complete questionnaire will take approximately 20-30 minutes to complete. The study will enroll up to 1,000 employed individuals (20 or more hours per week) whose work includes overnight shifts, with a minimum criterion of at least 4 night shifts a month. Health Care Workers who complete the Shift Worker Survey will be given the option to complete an additional Health Care Worker's Questionnaire at the end of the basic Shift Worker Survey. Those whose responses meet inclusion/exclusion criteria for the Field Trial will be informed at the end of the Shift Worker Survey that they may be eligible for the Field Trial.
The goal of the Focus Groups is to gain information on the feasibility and acceptability of the fixed 8-h sleep schedule from the participants' perspective. Investigators will seek to learn more information about the current sleep strategies they use on a regular basis, and both the facilitating and challenging aspects of the fixed-sleep countermeasure (e.g., individual, intrapersonal and organizational barriers to implementation of fixed 8-h sleep, recommended modifications to the fixed 8-h sleep schedule that would make it more user-friendly while maintaining scientific validity). Each of the focus groups will consist of 4-6 individuals to stimulate discussion without leaving participants out, and will last 60-90 minutes. The investigators aim to enroll up to 60 individuals in Focus Groups. In addition to the health care workers who took part in the Field Trial, the investigators will invite night shift workers who complete the Shift Worker Survey but indicate their inability to comply with a fixed 8-h sleep schedule to attend a Focus Group discussion.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The interventional study design describes the Field Trial only.
| Arm | Type | Receives |
|---|---|---|
| Control (Group A) | No intervention | –During the intervention block of the Field Trial, at the end of the first night shift, the participant will be told about their randomization group. In the control group (Group A), participants will not be given any instructions about the timing or duration of their sleep, but will be instructed to follow their usual night shift sleep routine. |
| 8-h Afternoon-Evening Sleep (Group B) | Experimental | Behavioral: 8-h Afternoon-Evening SleepIn the 8-h afternoon-evening sleep intervention group (Group B), participants will be instructed to go to bed between 13:00 and 14:00 (depending on their individual commute time) and to remain in bed attempting to sleep for 8 hours (until 21:00-22:00) before the next two night shifts. |
| 8-h Free Sleep (Group C) | Experimental | Behavioral: 8-h Free SleepIn the 8-h free sleep group (Group C), participants will be instructed to remain in bed for 8 continuous hours before the next two night shifts, but will not be given any instruction regarding which 8 hours they should sleep. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50-65 years
- Health care workers who work a minimum of 4 night shifts (8-4) per month
- Must live in the greater Boston area
- Must report an ability to work three successive 8-h night shifts during two weeks
- Must report an ability to spend 8 consecutive hours in bed attempting to sleep prior to the final two successive night shifts in the second study week
Key exclusion criteria (2 listed)
- Non-optional activities that would interfere with the participant's ability to remain in bed attempting to sleep if randomized to an 8-h sleep group
- Prescription or over-the-counter medication(s) known to affect sleep [e.g., hypnotics] or alertness [e.g., antihistamines]
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 |
|---|---|---|
| 8-h Afternoon-Evening Sleep8 consecutive hours time in bed during the afternoon/evening. | Behavioural | 8-h Afternoon-Evening Sleep (Group B) |
| 8-h Free Sleep8 consecutive hours time in bed at any time. | Behavioural | 8-h Free Sleep (Group C) |
Primary outcome
Total Sleep Time (TST)
Time frame: The TST averaged for up to 3 intervention nights (in minutes) will be compared between groups.
TST is calculated as minutes of sleep in the main sleep episode between shifts, derived from actigraphy data collected in 60 s epochs. The investigators will use a commercial software package to score the sleep. For control group participants who will sleep ad-lib, TST will be calculated for the major sleep episode but also will be summed across sleep episodes if they sleep in more than one bout.
Sleep Fragmentation Index (FI)
Time frame: The FI averaged for intervention nights 2 and 3 will be compared between groups.
FI will be calculated as the number of times that sleep was terminated after 1 minute, expressed as a percentage of total estimated sleep time, using actigraphy data and commercial software to calculate it.
Wake After Sleep Onset (WASO)
Time frame: The WASO averaged for intervention nights 2 and 3 will be compared between groups.
WASO is an objective sleep quality measure and will be calculated as the duration (in minutes) of all awakenings during the main sleep episode measured with actigraphy, and calculated using commercial software.
Subjective Sleep Quality
Time frame: Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.
Participants will report their subjective sleep quality daily upon awakening from the main sleep episode. Multiple measures of subjective sleep quality will be assessed, but the investigators will report how refreshed the participant feels after awakening as the outcome. This is rated on a 7-point scale, where 7 is the best and 1 is the worst.
Subjective Alertness Via Karolinska Sleepiness Scale (KSS)
Time frame: The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared to that at baseline.
Participants will complete the Karolinska Sleepiness Scale (KSS) as a measure of subjective alertness immediately following each night shift. The KSS is a Likert scale ranging from 1, extremely alert, to 9, extremely sleepy.
Sustained Attention
Time frame: PVT mean of slowest 10% of responses measured at the start of the final night shift (night shift 3) during the intervention block will be compared between groups.
The psychomotor vigilance task (PVT) is a test of visual reaction time (RT) in which the participant is asked to maintain the fastest possible RTs to a simple visual stimulus for several minutes. The inter-stimulus interval varies randomly between 2-10 seconds. While there are a number of standard performance metrics that can be obtained from each PVT, we have looked at the slowest 10% of responses.
Subjective Energy
Time frame: Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
A Visual Analogue Scale (VAS) will be used to assess subjective energy level. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. energetic-sluggish. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as subjective energeticness. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective energy.
Subjective Stress Via Visual Analog Scale (VAS)
Time frame: Subjective Stress via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
A Visual Analogue Scale (VAS) will be used to assess subjective stress.The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. relaxed-stressed. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Stress. Thus, scores on the scale range from 0 to 100 with higher scores indicating greater subjective stress.
Subjective Calmness Via Visual Analog Scale (VAS)
Time frame: Subjective Calmness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
A Visual Analogue Scale (VAS) will be used to assess subjective Calmness. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. calm-excited. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Calmness. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective calmness.
Subjective Health Via Visual Analog Scale (VAS)
Time frame: Subjective Health via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Visual Analogue Scales (VAS) will be used to assess subjective health. VAS consist of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. healthy-sick. The Participant indicates a position on the line that best describes how they feel at that moment. Distance from the left end of the scale (0) to the indicated point will be measured in mm and reported as Subjective Health. Thus, scores on the scale range from 0 to 100 with lower scores indicating greater subjective health.
Subjective Alertness Via Visual Analog Scale (VAS) - DATA NOT COLLECTED
Time frame: Subjective Alertness via VAS measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
Participants will complete the Visual Analog Scale (VAS) as a measure of subjective alertness three times per night shift: Once just before the night shift, once during their shift break, and once immediately following the night shift. The VAS consists of a 100mm horizontal line with each end of the line labeled with the extremes of a subjective continuum, e.g. sleepy-alert. Participants will indicate a position on the line that best describes how they feel at that moment. Distance from the left end of the scale to the indicated point will be measured in mm and reported as Subjective Alertness with higher scores indicating greater subjective alertness.
4 secondary outcomes
Fatigue and Inter-Shift Recovery
Time frame: OFER15 scores from the end of the third night shift in the Baseline to the end of the Intervention block will be compared between groups.
Subjective Stress
Time frame: Subjective stress will be assessed immediately after the third night shift in the Baseline and Intervention blocks and the change will be compared between groups.
Subjective Quality of Life: WHOQOLBref
Time frame: WHOQOL-Bref will be taken at Baseline and immediately after the third night shift in the Intervention block and will be compared between groups.
Salivary Cortisol Level NOTE THAT THIS AIM WAS DROPPED WHEN THE STUDY WENT TO FULLY REMOTE DUE TO COVID
Time frame: Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jeanne F Duffy, MBA, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-h Afternoon-Evening Sleep and 8-h Free Sleep in people with Shift-Work Sleep Disorder and Shift-Work Related Sleep Disturbance, run by Brigham and Women's Hospital 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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Sleep Time (TST) (time frame: The TST averaged for up to 3 intervention nights (in minutes) will be compared between groups.). The study lists 11 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 15 Aug 2025; AzTrials last refreshed its copy on 5 Nov 2026.