Validation of the Sustained Attention to Response Task (SART) for assessing the fitness to drive in narcolepsy and idiopathic hypersomnia patients

Validation of the Sustained Attention to Response Task (SART) for assessing the fitness to drive in narcolepsy and idiopathic hypersomnia patients - SART and driving fitness in narcolepsy and idiopathic hypersomnia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44358

Enrollment

Registered

2015-06-10

Start date

2015-06-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic hypersomnia Narcolepsy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of narcolepsy with or without cataplexy or a diagnosis of idiopathic hypersomnia according to ICSD-3 criteria (AASM 2014) 2. If medication is used, stable treatment within 6 weeks prior to testing is required. 3. Aged 18 years or above.

Exclusion criteria

Exclusion criteria: 1. Presence of other indications/medical disorders that require a driver fitness test (Regeling Eisen Geschiktheid, 2000). 2. Insufficient mastery of Dutch language.

Design outcomes

Secondary

Measure	Time frame
The secondary endpoints of the study are: - skin temperature measured with iButtons (sensors) - eye blinks measured with electro-oculogram (EOG) - subjective sleepiness measured with multiple questionnaires - subjective driving quality measured with a visual analogue scale - subjective driving effort measured with a visual analogue scale	—

Primary

Measure	Time frame
The primary endpoints of the study are, for the MWT: sleep latency, for the SART: error scores and for the on-the-road driving test: standard deviation of lateral position (SDLP).	—

Countries

Netherlands

Outcome results