Primary aim is to validate the SART as a screenings instrument for driver fitness in patients with narcolepsy and idiopathic hypersomnia.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
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
Background summary
Excessive daytime sleepiness (EDS) is a core symptom of narcolepsy and
idiopathic hypersomnia (IH). Sleepiness at the wheel obviously negatively
impacts driving performance. Therefore, assessing the fitness to drive is
formally required in individuals with EDS. The assessment is intended to
determine patient*s ability to stay alert while driving. For this, the
Maintenance of Wakefulness Test (MWT) is adopted by Dutch government in the
assessment of driving fitness in narcolepsy and IH. However, the MWT is time
consuming, labor-intensive and therefore too expensive compared to legal price
limits for driving fitness assessments . Recent studies suggest that the
Sustained Attention to Response Task (SART), a brief, computerized task, is a
promising alternative to detect impaired vigilance in narcolepsy and IH. If
SART results correspond to MWT results, the SART might be a more cost effective
alternative than the MWT in the evaluation of fitness to drive in narcolepsy
and IH patients. Moreover, comparing the SART with on-the-road driving
performance will further support its use.
Study objective
Primary aim is to validate the SART as a screenings instrument for driver
fitness in patients with narcolepsy and idiopathic hypersomnia.
Study design
The study consists of two parts. In the primary part of the study (part 1) the
outcomes of the SART will be compared to the outcomes of the MWT in a group of
narcolepsy and IH patients being evaluated for fitness to driving. In the
secondary part of the study (part 2) MWT and SART outcomes will be compared to
those of an on-the-road driving test in a subset of patients.
Study burden and risks
Participation in the primary part of the study comprises one visit to a sleep
clinic for a regular assessment of fitness to drive using the MWT, extended
with four assessments of their performance in the SART and measurement of skin
temperature. No complications of the SART are expected. Duration of this visit
is approximately 8 hours. Participants are not financially rewarded for
participation, except for receiving a free driving fitness assessment.
Participation in the secondary part of the study comprises one visit to
Maastricht University for performance measurement using a standardized
on-the-road driving test, the SART, and a psychomotor vigilance task. During
the driving test skin temperature will be measured. Duration of this visit is
approximately 6 hours. Participants will be compensated for travelling expenses
and will be financially rewarded with a ยค50 cheque . The on-the-road driving
task is not expected to cause any substantial risk to the patient, apart from
risks that are inherent to motorized traffic. Safety during the highway driving
task is ensured by a licensed driving instructor accompanying the participant.
The instructor has access to dual controls and can take over driving when he
feels the participant is too drowsy to continue safely.
Plesmanweg 1-6
Den Haag 2597 JG
NL
Plesmanweg 1-6
Den Haag 2597 JG
NL
Listed location countries
Age
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
1. Presence of other indications/medical disorders that require a driver fitness test (Regeling Eisen Geschiktheid, 2000).
2. Insufficient mastery of Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50579.068.14 |