Assessment of vigilance using pupillometry in epilepsy, idiopathic hypersomnia and narcolepsy

Completed

• Conditions: Epilepsie; idiopathic hypersomnia; Narcolepsy; epilepsy; excessive daytime sleepiness; 10040998; 10021112

• Registration Number: NL-OMON47847
• Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-02-20
• Results First Posted: 2021-02-18
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 47

Inclusion Criteria

Subjects are > 18 years
Diagnosed in one of the below mentioned categories:
1. Epileptic patients with seizures only during the night for at least the last year
2. Epileptic patients with seizures only during the day for at least the last year
3. Type 1 narcolepsy patients
4. Type 2 narcolepsy patients
5. Idiopathic hypersomnia
6. Healthy controls

Exclusion Criteria

- Color vision deficiency
- Recent (< 8 weeks) change in vigilance-influencing medication regime
- Use of eye drops
- Unable to sit
- Diseases with vision deficiencies and sleep disorders apart from narcolepsy and idiopathic hypersomnia

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>As the primary endpoint, responsiveness to light will be measured using the<br /><br>pupillometer, measuring the diameter of the pupil while exposed to no light,<br /><br>red light and blue light, resulting in the Post-illumination Pupillary Response<br /><br>(PIPR) (Van der Meijden et al., 2015). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are vigilance as measured by the SART (total error score<br /><br>Van Schie et al., 2012) and the ESS. In addition, we will assess habitual sleep<br /><br>timing from the MCTQ, fatigue with the FSS and sleep quality from the PSQI.</p><br>