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Sleep and Circadian Treatments for Shift Workers

Sleep and Circadian Treatments for Shift Workers

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03813654
Enrollment
33
Registered
2019-01-23
Start date
2020-08-20
Completion date
2023-12-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shift-Work Related Sleep Disturbance, Shift-Work Sleep Disorder

Keywords

sleep, attention, vigilance, aging, shift work

Brief 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. 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.

Interventions

BEHAVIORAL8-h Afternoon-Evening Sleep

8 consecutive hours time in bed during the afternoon/evening.

BEHAVIORAL8-h Free Sleep

8 consecutive hours time in bed at any time.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Massachusetts, Lowell
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The interventional study design describes the Field Trial only.

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

Field Trial - Inclusion Criteria: * 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

Exclusion criteria

* 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 \[e.g., antihistamines\]

Design outcomes

Primary

MeasureTime frameDescription
Subjective Alertness Via Visual Analog Scale (VAS) - DATA NOT COLLECTEDSubjective 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.
Subjective EnergySubjective 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)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)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)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.
Total Sleep Time (TST)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)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)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 QualitySubjective 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)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 AttentionPVT 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.

Secondary

MeasureTime frameDescription
Subjective StressSubjective stress will be assessed immediately after the third night shift in the Baseline and Intervention blocks and the change will be compared between groups.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).
Subjective Quality of Life: WHOQOLBrefWHOQOL-Bref will be taken at Baseline and immediately after the third night shift in the Intervention block and will be compared between groups.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).
Salivary Cortisol Level NOTE THAT THIS AIM WAS DROPPED WHEN THE STUDY WENT TO FULLY REMOTE DUE TO COVIDSalivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.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.
Fatigue and Inter-Shift RecoveryOFER15 scores from the end of the third night shift in the Baseline to the end of the Intervention block will be compared between groups.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.

Countries

United States

Participant flow

Recruitment details

Recruitment took place between September 2019 and November 2022. All recruitment was via advertisements placed online, in newsletters, and through email lists.

Pre-assignment details

Enrollment was assigned upon start of the Baseline period, but participants were not informed of their randomization until after the first night shift of the Intervention period.

Participants by arm

ArmCount
Control (Group A)
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.
10
8-h Afternoon-Evening Sleep (Group B)
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. 8-h Afternoon-Evening Sleep: 8 consecutive hours time in bed during the afternoon/evening.
10
8-h Free Sleep (Group C)
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. 8-h Free Sleep: 8 consecutive hours time in bed at any time.
9
Total29

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation012
Overall StudyWithdrawal by Subject100

Baseline characteristics

CharacteristicControl (Group A)8-h Afternoon-Evening Sleep (Group B)8-h Free Sleep (Group C)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants9 Participants29 Participants
Age, Continuous54.6 years
STANDARD_DEVIATION 4.2
58.3 years
STANDARD_DEVIATION 5
58.6 years
STANDARD_DEVIATION 2.9
56.5 years
STANDARD_DEVIATION 4.3
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants10 Participants9 Participants29 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
9 Participants8 Participants8 Participants25 Participants
Region of Enrollment
United States
10 participants10 participants9 participants29 participants
Sex: Female, Male
Female
9 Participants7 Participants7 Participants23 Participants
Sex: Female, Male
Male
1 Participants3 Participants2 Participants6 Participants
Years Working Night Shifts
11-24 years
3 participants5 participants2 participants10 participants
Years Working Night Shifts
1-5 years
1 participants1 participants1 participants3 participants
Years Working Night Shifts
6-10 years
1 participants1 participants1 participants3 participants
Years Working Night Shifts
less than 1 year
1 participants0 participants1 participants2 participants
Years Working Night Shifts
more than 25 years
4 participants3 participants4 participants11 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 9
other
Total, other adverse events
1 / 100 / 101 / 9
serious
Total, serious adverse events
0 / 100 / 100 / 9

Outcome results

Primary

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.

Time frame: The FI averaged for intervention nights 2 and 3 will be compared between groups.

Population: All participants with useable actigraphy data were included.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Sleep Fragmentation Index (FI)22.15 percentage of TSTStandard Deviation 15.49
8-h Afternoon-Evening Sleep (Group B)Sleep Fragmentation Index (FI)34.94 percentage of TSTStandard Deviation 22.01
8-h Free Sleep (Group C)Sleep Fragmentation Index (FI)29.25 percentage of TSTStandard Deviation 15.45
Primary

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.

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.

Population: All participants completing the study for whom data were available.

ArmMeasureGroupValue (NUMBER)
Control (Group A)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness did not change between baseline and end of treatment3 participants
Control (Group A)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness worsened between baseline and end of treatment5 participants
Control (Group A)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness improved between baseline and end of treatment1 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness did not change between baseline and end of treatment3 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness worsened between baseline and end of treatment0 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness improved between baseline and end of treatment4 participants
8-h Free Sleep (Group C)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness worsened between baseline and end of treatment3 participants
8-h Free Sleep (Group C)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness improved between baseline and end of treatment2 participants
8-h Free Sleep (Group C)Subjective Alertness Via Karolinska Sleepiness Scale (KSS)subjective sleepiness did not change between baseline and end of treatment4 participants
Primary

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.

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.

Population: These data are similar enough to measures from the Karolinska Sleepiness Scale data and in order to reduce participant burden WE DID NOT COLLECT THEM. We did not modify the IRB protocol to indicate this measure would not be collected. BECAUSE THEY WERE NOT COLLECTED WE CANNOT ANALYZE ANYTHING.

Primary

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.

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.

Population: All participants who had data collected at the end of the 3rd Night Shift.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Subjective Calmness Via Visual Analog Scale (VAS)80.14 units on a scale of 0-100Standard Deviation 19.64
8-h Afternoon-Evening Sleep (Group B)Subjective Calmness Via Visual Analog Scale (VAS)78.34 units on a scale of 0-100Standard Deviation 15.42
8-h Free Sleep (Group C)Subjective Calmness Via Visual Analog Scale (VAS)78.51 units on a scale of 0-100Standard Deviation 14.54
Primary

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.

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.

Population: All participants who had data collected at the end of Intervention Night Shift 3.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Subjective Energy50.07 units on a scale of 0-100Standard Deviation 27.17
8-h Afternoon-Evening Sleep (Group B)Subjective Energy57.72 units on a scale of 0-100Standard Deviation 28.95
8-h Free Sleep (Group C)Subjective Energy52.07 units on a scale of 0-100Standard Deviation 22.53
Primary

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.

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.

Population: All participants who had data from the end of Intervention Night Shift 3.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Subjective Health Via Visual Analog Scale (VAS)75.08 units on a scale of 0-100Standard Deviation 15.12
8-h Afternoon-Evening Sleep (Group B)Subjective Health Via Visual Analog Scale (VAS)78.88 units on a scale of 0-100Standard Deviation 19.05
8-h Free Sleep (Group C)Subjective Health Via Visual Analog Scale (VAS)74.96 units on a scale of 0-100Standard Deviation 16.78
Primary

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.

Time frame: Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.

Population: Every participant with responses at waketime after night shifts 2 and/or 3 during the intervention segment.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Subjective Sleep Quality3.25 units on a scaleStandard Deviation 1.03
8-h Afternoon-Evening Sleep (Group B)Subjective Sleep Quality3.06 units on a scaleStandard Deviation 1.36
8-h Free Sleep (Group C)Subjective Sleep Quality3.13 units on a scaleStandard Deviation 0.88
Primary

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.

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.

Population: All participants who had data collected at the end of intervention night shift 3.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Subjective Stress Via Visual Analog Scale (VAS)58.99 units on a scale of 0-100Standard Deviation 32.33
8-h Afternoon-Evening Sleep (Group B)Subjective Stress Via Visual Analog Scale (VAS)68.84 units on a scale of 0-100Standard Deviation 20.29
8-h Free Sleep (Group C)Subjective Stress Via Visual Analog Scale (VAS)76.52 units on a scale of 0-100Standard Deviation 19.53
Primary

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.

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.

Population: There were many missing data for this outcome. Group A only had 1 participant in whom complete PVT results were available for the final night shift. Thus, no standard deviation is provided.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Sustained Attention308.75 millisecondsStandard Deviation 0
8-h Afternoon-Evening Sleep (Group B)Sustained Attention393.27 millisecondsStandard Deviation 87.34
8-h Free Sleep (Group C)Sustained Attention470.96 millisecondsStandard Deviation 126.8
Comparison: We compared the PVT taken at the start of the final night shift between Group B and those in Group C who slept in the morning and had complete data. Our hypothesis was that Group B would have faster RTs.p-value: 0.09t-test, 1 sided
Primary

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.

Time frame: The TST averaged for up to 3 intervention nights (in minutes) will be compared between groups.

Population: All participants with useable actigraphy data were included.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Total Sleep Time (TST)338 minutesStandard Deviation 68.7
8-h Afternoon-Evening Sleep (Group B)Total Sleep Time (TST)387 minutesStandard Deviation 53.2
8-h Free Sleep (Group C)Total Sleep Time (TST)428 minutesStandard Deviation 66.7
p-value: <0.05Mixed Models Analysis
Primary

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.

Time frame: The WASO averaged for intervention nights 2 and 3 will be compared between groups.

Population: All participants with useable actigraphy data were included.

ArmMeasureValue (MEAN)Dispersion
Control (Group A)Wake After Sleep Onset (WASO)38.85 minutesStandard Deviation 32.69
8-h Afternoon-Evening Sleep (Group B)Wake After Sleep Onset (WASO)83.18 minutesStandard Deviation 57.96
8-h Free Sleep (Group C)Wake After Sleep Onset (WASO)70.06 minutesStandard Deviation 43.6
Secondary

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.

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.

Population: All participants who completed the study and who had complete questionnaire results from the Baseline and Intervention.

ArmMeasureGroupValue (NUMBER)
Control (Group A)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores did not change between baseline and end of intervention.0 participants
Control (Group A)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores worsened between baseline and end of intervention.3 participants
Control (Group A)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores improved between baseline and end of intervention.5 participants
Control (Group A)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores improved between baseline and end of intervention.5 participants
Control (Group A)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores worsened between baseline and end of intervention.3 participants
8-h Afternoon-Evening Sleep (Group B)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores worsened between baseline and end of intervention.2 participants
8-h Afternoon-Evening Sleep (Group B)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores improved between baseline and end of intervention.4 participants
8-h Afternoon-Evening Sleep (Group B)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores worsened between baseline and end of intervention.3 participants
8-h Afternoon-Evening Sleep (Group B)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores did not change between baseline and end of intervention.1 participants
8-h Afternoon-Evening Sleep (Group B)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores improved between baseline and end of intervention.2 participants
8-h Free Sleep (Group C)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores improved between baseline and end of intervention.1 participants
8-h Free Sleep (Group C)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores did not change between baseline and end of intervention.0 participants
8-h Free Sleep (Group C)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores worsened between baseline and end of intervention.4 participants
8-h Free Sleep (Group C)Fatigue and Inter-Shift RecoveryParticipants whose refreshment scores worsened between baseline and end of intervention.7 participants
8-h Free Sleep (Group C)Fatigue and Inter-Shift RecoveryParticipants whose fatigue scores improved between baseline and end of intervention.4 participants
Secondary

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.

Time frame: Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.

Population: These data were not collected and therefore could not be analyzed. When the study had to go fully remote due to COVID, we dropped this Aim. This was reported in our NIH Progress Report in 2020.

Secondary

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).

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.

Population: All participants who completed the study and who had baseline and end of intervention data.

ArmMeasureGroupValue (NUMBER)
Control (Group A)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score did not change from baseline to end of intervention.2 participants
Control (Group A)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score declined from baseline to end of intervention.5 participants
Control (Group A)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score improved from baseline to end of intervention.2 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score did not change from baseline to end of intervention.3 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score improved from baseline to end of intervention.1 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score declined from baseline to end of intervention.2 participants
8-h Free Sleep (Group C)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score did not change from baseline to end of intervention.1 participants
8-h Free Sleep (Group C)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score declined from baseline to end of intervention.3 participants
8-h Free Sleep (Group C)Subjective Quality of Life: WHOQOLBrefparticipants whose QOL score improved from baseline to end of intervention.5 participants
Secondary

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).

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.

Population: All participants who completed the study and who had Baseline and Intervention data.

ArmMeasureGroupValue (NUMBER)
Control (Group A)Subjective Stressparticipants whose perceived stress did not change from baseline to end of intervention.1 participants
Control (Group A)Subjective Stressparticipants whose perceived stress worsened from baseline to end of intervention.3 participants
Control (Group A)Subjective Stressparticipants whose perceived stress improved from baseline to end of intervention.5 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Stressparticipants whose perceived stress did not change from baseline to end of intervention.1 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Stressparticipants whose perceived stress worsened from baseline to end of intervention.3 participants
8-h Afternoon-Evening Sleep (Group B)Subjective Stressparticipants whose perceived stress improved from baseline to end of intervention.2 participants
8-h Free Sleep (Group C)Subjective Stressparticipants whose perceived stress worsened from baseline to end of intervention.2 participants
8-h Free Sleep (Group C)Subjective Stressparticipants whose perceived stress improved from baseline to end of intervention.5 participants
8-h Free Sleep (Group C)Subjective Stressparticipants whose perceived stress did not change from baseline to end of intervention.2 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026