RecruitingACTRN12615001224516

Novel brain biomarkers of performance impairment in good sleepers

Novel brain biomarkers of driving and vigilance performance in those with good sleep during extended wakefulness


Sponsor

Cooperative Research Centre (CRC) for Alertness, Safety and Productivity

Enrollment

50 participants

Start Date

Sep 2, 2015

Study Type

Interventional

Conditions

Summary

This neurobehavioural dysfunction, such as impaired driving ability, has a critical impact on health and society. Many individuals underestimate their impairment and there is wide inter-individual variability in how individuals are affected by sleepiness and its consequences. For example, some may report few symptoms while others with apparent mild disease exhibit severe sleepiness. Unravelling this problem of interindividual variability demands better assessment tools as conventional metrics such as sleep studies are uninformative. In this study, simulated driving and other performance tasks will be administered during a load of prolonged wakefulness extending throughout the night to unmask variation in neurobehavoural function. Performance under these conditions will be used to assess individual risk of vigilance failure such as impaired driving, and aid in the development of practically deployable biomarkers for predicting vulnerability to vigilance failure.


Eligibility

Sex: Both males and femalesMin Age: 25 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is measuring brain and performance changes in healthy sleepers when they stay awake through the night. Researchers want to find brain signals that predict who is most at risk of impaired performance — such as poor driving — when sleep-deprived. The study uses simulated driving tests and brain monitoring. The goal is to develop tools that can detect dangerous sleepiness before accidents happen. You may be eligible if: - You are between 25 and 65 years old - You weigh under 150 kg - You can read and speak English - You can perform computer-based tests You may NOT be eligible if: - You have been diagnosed with a sleep disorder (such as sleep apnea) confirmed by a sleep study - You have a history of head injury, epilepsy, depression, stroke, mania, or psychosis - You currently use medications that affect the brain and nervous system (antidepressants, antipsychotics, opiates, antihistamines) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

50 healthy individuals will be recruited to undergo an experimental laboratory protocol following a screening visit and after obtaining informed consent. One week of actigraphy and sleep-wake diary an

50 healthy individuals will be recruited to undergo an experimental laboratory protocol following a screening visit and after obtaining informed consent. One week of actigraphy and sleep-wake diary and indoor-outdoor activity logs, will be performed prior to the test visit to measure sleep hours and activities at home, and participants will be advised to observe regular sleep hours with 8-hours in bed. The experimental protocol visit consists: - baseline sleep study followed by 28 hours of extended wakefulness challenge (EWC) with detailed assessment including: Primary performance outcomes measure -Three 90 minute computerised AusEd driving simulator tasks measured at Time 1 (9.30am, 3.5 hours awake), Time 2 (2.30am, 20.5 hours awake) and Time 3 (8.30am, 26.5 hours awake) Secondary performance outcome measure -10 minute psychomotor vigilance test (PVT) measures every 2 hours throughout the EWC starting from midday. Primary Predictor Variables -Baseline sleep study is performed from 10pm-6am (EEG data will be subjected to spectral power analysis as part of data processing/analysis) -Auditory Event Related potentials (ERP) data will be collected at between 8.30-9.30am (baseline assessment only) -Resting awake EEG during a 7 minute Karolinska Drowsiness Test measure every 2 hours throughout the EWC startinf at midday -Magnetic Resonance Spectroscopy/Diffusion Tensor Imaging occurs within 1 week prior to laboratory EWC visit (assessed at baseline only) Secondary Predictor Variables -mRNA expression profiles from baseline to end of EWC (blood/mRNA samples collected at 6.15am upon awakening and 6.15am the following morning after 24hours of wakefulness -Posture/Balance control assessments measured every 2 hours throughout the EWC starting at midday -Peripheral Blood Pressure measures every 2 hours throughout the EWC starting at midday Computerised performance tests measure every 2 hours through out the EWC starting at midday : - Working memory (N-back 1,2,3) - Visuomotor skills (Digit Symbol Substitution Task) - 4 Choice Reaction Time Task - Letter Cancellation Task - Emotion Perception Task - Thermal sensation scale - Central Blood Pressure and Pulse Wave Analysis (PWA) measures every 2 hours throughout the EWC starting at midday - Statistical Learning Task measured at baseline (8.30pm prior to baseline sleep study) and at 8.30pm 24 hours later. - Actigraphy variables (actigraphy data collected 1 week prior to EWC) - PSG sleep study variables (collected during the baseline sleep study just prior to EWC) - Genetic polymorphisms (genetic analysis from blood samples collected at start and end of EWC will occur at the completion of the study) - Inflammatory marker profiles (from blood sample analysis collected at start and end of EWC will occur at the completion of the study) - Brief Smell Identification Test (B-SIT) is collected at baseline only at 7.30pm prior to baseline sleep study - State anxiety questionnaire administered every 2 hours throughout the EWC starting at midday - Karolinska Sleepiness Scale administered every 2 hours throughout the EWC starting at midday


Locations(1)

NSW, Australia

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ACTRN12615001224516