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Fitbit Inspire HR Wrist Worn Device (NCT04176926) for Shift Work Sleep Disorder

N/A
Waitlist Available
Led By Kaylie A Green, M.S.
Research Sponsored by Pacific University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
Awards & highlights

Study Summary

This study is evaluating whether a CBT-I intervention is feasible and acceptable for firefighters.

Eligible Conditions
  • Shift Work Sleep Disorder
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (i.e., pre-intervention), 6 weeks (i.e., post-intervention), 18 weeks (i.e., 3-month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability as measured by mean acceptability ratings on four Likert-style questions.
Change in Scores on the Pittsburgh Sleep Quality Index (PSQI)
Feasibility as measured by attendance, attrition, and adherence to intervention components.
+1 more
Secondary outcome measures
Depression, Anxiety, and Stress as Measured Through the Depression, Anxiety, and Stress Scales 21 (DASS-21).
Family Functioning as Measured Through the McMaster Family Assessment Device - General Functioning Scale (FAD-GFS)
Fidelity of Intervention Protocol Across Sessions
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) [Treatment Group]Experimental Treatment2 Interventions
The Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F) is a 6-week training course that focuses on mitigating poor sleep quality and promoting the adoption of behaviors conducive to quality sleep. This course includes modules on developing habits conducive to better sleep, adapting variable bedroom environments, and establishing techniques to reduce worry and frustration around falling asleep while recognizing and working through barriers unique to the career of firefighting.
Group II: No Intervention Control GroupActive Control1 Intervention
Non-Intervention Control Group (NIC) will not receive training during the course of the study, but will be offered the opportunity to receive training after the study ends.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy for Insomnia for Firefighters (CBT-I-F)
2021
N/A
~30
Fitbit Inspire HR Wrist Worn Device (NCT04176926)
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Pacific UniversityLead Sponsor
13 Previous Clinical Trials
1,099 Total Patients Enrolled
Kaylie A Green, M.S.Principal InvestigatorPacific University
Michael Christopher, Ph.D.Study ChairPacific University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
2021. "A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05087121.
~6 spots leftby Apr 2025
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