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Sleep Interventions for Shift Work Sleep Disorder

N/A
Waitlist Available
Led By Jeanne F Duffy, MBA, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up whoqol-bref will be taken immediately after the third night shift in the intervention block and will be compared between groups.
Awards & highlights

Study Summary

This trial will study the feasibility and effectiveness of an 8-hour sleep intervention for older night shift workers. The goal is to reduce sleep deficiency and its negative effects, like sleepiness and performance impairments.

Who is the study for?
This trial is for healthcare workers aged 50-65 in the Boston area who work at least four night shifts a month. They must be able to do three consecutive night shifts and spend eight hours in bed before the last two. Those with activities or medications affecting sleep or alertness can't join.Check my eligibility
What is being tested?
The study tests if an 8-hour sleep intervention helps older night shift workers get better rest, feel less sleepy, and perform better on the job. It includes a field trial, survey to understand worker habits, and focus groups for those hesitant about the sleep strategy.See study design
What are the potential side effects?
Since this isn't a drug trial but rather a behavioral intervention focusing on sleep patterns, there are no direct side effects like you'd expect from medication. However, changing sleep schedules could temporarily affect mood or alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are between 50 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~salivary cortisol will be assessed immediately after the third night shift in the intervention block and levels will be compared between groups.
This trial's timeline: 3 weeks for screening, Varies for treatment, and salivary cortisol will be assessed immediately after the third night shift in the intervention block and levels will be compared between groups. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep Fragmentation Index (FI)
Subjective Alertness via Karolinska Sleepiness Scale (KSS)
Subjective Alertness via Visual Analog Scale (VAS)
+8 more
Secondary outcome measures
Fatigue and Inter-Shift Recovery
Salivary Cortisol Level
Subjective Quality of Life: WHOQOLBref
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: 8-h Free Sleep (Group C)Experimental Treatment1 Intervention
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 II: 8-h Afternoon-Evening Sleep (Group B)Experimental Treatment1 Intervention
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 III: Control (Group A)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
8-h Afternoon-Evening Sleep
2020
N/A
~40
8-h Free Sleep
2020
N/A
~40

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,611 Previous Clinical Trials
11,470,488 Total Patients Enrolled
Jeanne F Duffy, MBA, PhDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
105 Total Patients Enrolled

Media Library

8-h Afternoon-Evening Sleep Clinical Trial Eligibility Overview. Trial Name: NCT03813654 — N/A
Shift Work Sleep Disorder Research Study Groups: Control (Group A), 8-h Afternoon-Evening Sleep (Group B), 8-h Free Sleep (Group C)
Shift Work Sleep Disorder Clinical Trial 2023: 8-h Afternoon-Evening Sleep Highlights & Side Effects. Trial Name: NCT03813654 — N/A
8-h Afternoon-Evening Sleep 2023 Treatment Timeline for Medical Study. Trial Name: NCT03813654 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings still available to participants of this trial?

"Affirmative, clinicaltrials.gov data reveals that this trial is recruiting patients at the present time. The medical study was first published on August 20th 2020 and recently updated on November 3rd 2021. Approximately 75 participants are set to be enrolled from one site."

Answered by AI

How many individuals can enroll in this medical trial?

"Affirmative. According to clinicaltrials.gov, recruitment for this medical study has been ongoing since August 20th 2020 and is still active as of November 3rd 2021. 75 individuals are required from 1 research centre for enrolment in the trial."

Answered by AI

Is the current experiment recruiting individuals who are over 45 years of age?

"This trial is recruiting individuals aged between 50 and 65 years old."

Answered by AI

How is this research attempting to advance medicine?

"This clinical trial has two primary goals that will be evaluated at the end of its third night shift in the intervention block. Firstly, it seeks to measure Subjective Stress through a Visual Analog Scale (VAS). Additionally, Secondary objectives include gauging Fatigue and Inter-Shift Recovery with The Occupational Fatigue Exhaustion Recovery Scale (OFER 15) as well as measuring Quality of Life via WHOQOLBref and assessing Subjective Stress levels using The Daily Stress Inventory (DSI). Each questionnaire is answered on a Likert scale ranging from 0 to 6 or 1 to 5 respectively."

Answered by AI

Who meets the criteria to join this research endeavor?

"This sleep disorder study seeks 75 individuals aged between 50 and 65. Qualifying requirements include the capacity to complete three consecutive 8-hour night shifts over a two week period, being employed in healthcare with at least four nocturnal assignments each month, and having an expeditious commute from home to workplace of less than sixty minutes."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sleep and Circadian Treatments for Shift Workers
Jeanne Duffy 2020. "Sleep and Circadian Treatments for Shift Workers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03813654.
~7 spots leftby Apr 2025
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