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Clinical Trials/ACTRN12621001610820
ACTRN12621001610820
Recruiting
未知

Determining the effectiveness of vestibular and ocular motor function screening assessments for identifying sleepy drivers.

Flinders University of South Australia0 sites30 target enrollmentNovember 26, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Flinders University of South Australia
Enrollment
30
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 26, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Flinders University of South Australia

Eligibility Criteria

Inclusion Criteria

  • Inclusion – eligible participants must meet all of the following criteria:
  • \-Held their full car license (class C) for a minimum of two years
  • \-Drive at least 3 hours per week
  • \-Bedtime 2200 ±2hrs; waketime 0800 ±2hrs; between 6\-11 hours in bed
  • \-Reading/Speaking English fluency
  • \-Able to give informed, written consent
  • \-Age/gender matched (i.e., aim to recruit equal numbers of male/female participants whose ages match to ensure a representative sample of individuals in this age group (20\-35 years old)
  • Comprehensive/Questionnaires
  • \-Insomnia Severity Index (ISI) \<10
  • \-Epworth Sleepiness Score (ESS) \<10

Exclusion Criteria

  • Exclusion – eligible participants will not exhibit any of the following:
  • \-Active Health/mental health/sleep conditions that alter sleep; or BMI \>35
  • \-History of TBI, stroke, or neurodegenerative disorder (Parkinson’s disease, Dementia)
  • \-Active use of OTC or prescription medications that alter sleep (previous 2 months)
  • \-Active illicit substance use (previous 2 months)
  • \-Elevated alcohol and caffeine use (\>4 x alcohol and/or caffeine drinks per day; OR \>10 alcoholic drinks per week)
  • \-Smoking dependence (non\-casual smoking)
  • \-Pregnancy, lactating, or caring for a newborn (12 months and under)
  • \-Recent overnight shift workers (working 2300\-0600 at least once per week in previous 2 months); recent time\-zone travel encompassing \>2 zones (previous 2 months)

Outcomes

Primary Outcomes

Not specified

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