Sleep and Circadian Treatments for Shift Workers

NCT ID: NCT03813654

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-20
• Study Completion Date: 2023-12-31

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.

Conditions

Shift-Work Sleep Disorder; Shift-Work Related Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

8-h Afternoon-Evening Sleep

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

8-h Free Sleep

Intervention Type: BEHAVIORAL

8 consecutive hours time in bed at any time.

Interventions

8-h Afternoon-Evening Sleep

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

Intervention Type: BEHAVIORAL

8-h Free Sleep

8 consecutive hours time in bed at any time.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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]

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Massachusetts, Lowell

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Duffy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne F Duffy, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AG044416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-P-002341

Identifier Type: -

Identifier Source: org_study_id