Sleep and Circadian Treatments for Shift Workers

Shift-Work Sleep Disorder Clinical Trial

Official title: Sleep and Circadian Treatments for Shift Workers

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Shift-Work Related Sleep Disturbance
• Shift-Work Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

• NCT number: NCT03813654
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Completion date: December 31, 2023