Sleep and Circadian Treatments for Shift Workers
Condition: Shift-Work Sleep Disorder; Shift-Work Related Sleep Disturbance
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Disorders, Circadian Rhythm
Study type: Interventional

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.
    

Intervention name(s): 8-h Afternoon-Evening Sleep; 8-h Free Sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 consecutive hours time in bed during the afternoon/evening.; 8 consecutive hours time in bed at any time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The interventional study design describes the Field Trial only.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: sleep; attention; vigilance; aging; shift work