Clinical trial NCT03813654: Sleep and Circadian Treatments for Shift Workers
Official title: Sleep and Circadian Treatments for Shift Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Shift-Work Related Sleep Disturbance
Keywords: sleep
attention
vigilance
aging
shift work
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study design describes the Field Trial only.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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 \[e.g., antihistamines\]

Primary outcomes:
measure: Total Sleep Time (TST)
timeFrame: The TST averaged for intervention nights 2 and 3 (in minutes) will be compared between groups.
measure: Sleep Fragmentation Index (FI)
timeFrame: The FI averaged for intervention nights 2 and 3 will be compared between groups.
measure: Wake After Sleep Onset (WASO)
timeFrame: The WASO averaged for intervention nights 2 and 3 will be compared between groups.
measure: Subjective Sleep Quality
timeFrame: Subjective Sleep quality (refreshment) averaged for intervention nights 2 and 3 will be compared between groups.(
measure: Subjective Alertness via Karolinska Sleepiness Scale (KSS)
timeFrame: The KSS score taken at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
measure: Sustained Attention
timeFrame: PVT mean lapses of attention measured at the end of the final night shift (night shift 3) during the intervention block will be compared between groups.
measure: Subjective Energy
timeFrame: Subjective Energy measurements taken at the end of the final night shift (night shift 3) in the intervention block will be compared between groups.
measure: Subjective Stress via Visual Analog Scale (VAS)
timeFrame: 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.
measure: Subjective Calmness via Visual Analog Scale (VAS)
timeFrame: 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.
measure: Subjective Health via Visual Analog Scale (VAS)
timeFrame: 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.
measure: Subjective Alertness via Visual Analog Scale (VAS)
timeFrame: 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:
measure: Fatigue and Inter-Shift Recovery
timeFrame: OFER15 scores from the end of the third night shift in the Intervention block will be compared between groups.
measure: Subjective Stress
timeFrame: Subjective stress will be assessed immediately after the third night shift in the Intervention block and will be compared between groups.
measure: Subjective Quality of Life: WHOQOLBref
timeFrame: WHOQOL-Bref will be taken immediately after the third night shift in the Intervention block and will be compared between groups.
measure: Salivary Cortisol Level
timeFrame: Salivary Cortisol will be assessed immediately after the third night shift in the Intervention block and levels will be compared between groups.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeanne F Duffy, MBA, PhD
role: PRINCIPAL_INVESTIGATOR
References: