Sodium Oxybate for the Treatment of Vigilance Impairment in Narcolepsy

Sodium Oxybate for the Treatment of Vigilance Impairment in Narcolepsy - Sodium Oxybate and Vigilance in Narcolepsy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30579

Enrollment

Registered

2007-07-16

Start date

2006-05-30

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Narcolepsy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Definite narcolepsy-cataplexy, according to international criteria [AASM 2005], - Patients have to be treatment-naive and planning to start sodium oxybate or already using sodium oxybate and prepared to stop medication at least 14 days prior to study start

Exclusion criteria

Exclusion criteria: - Younger than 18 or older than 70 years - Cognitive impairment due to neurological disorders other than sleep-wake disorders - Use of other hypnotics or other sleep-wake active drugs

Design outcomes

Primary

Measure	Time frame
Core: 1. Is it feasible to measure vigilance using a portable task battery for seven days? 2. Can impaired vigilance in narcolepsy be detected when compared to healthy controls? 3. Does treatment with sodium oxybate in narcoleptics improve performance on this portable task battery? 4. Does stable treatment with sodium oxybate have an effect on activity levels as measured by wrist actigraph? Optional Part 1: 1. Do narcoleptic patients have a different thermoregulatory profile during daily routine and during nocturnal sleep compared to controls. 2. Is the thermoregulatory profile in narcoleptic patients related to the occurrence of sleep attacks 3. Does treatment influence the thermoregulatory profile of narcoleptic patients during daily routine and nocturnal sleep. Optional Part 2: 1. Does stable treatment with sodium oxybate have an effect on OSLER sleep latency?	—

Measure

Time frame

Core: 1. Is it feasible to measure vigilance using a portable task battery for seven days? 2. Can impaired vigilance in narcolepsy be detected when compared to healthy controls? 3. Does treatment with sodium oxybate in narcoleptics improve performance on this portable task battery? 4. Does stable treatment with sodium oxybate have an effect on activity levels as measured by wrist actigraph? Optional Part 1: 1. Do narcoleptic patients have a different thermoregulatory profile during daily routine and during nocturnal sleep compared to controls. 2. Is the thermoregulatory profile in narcoleptic patients related to the occurrence of sleep attacks 3. Does treatment influence the thermoregulatory profile of narcoleptic patients during daily routine and nocturnal sleep. Optional Part 2: 1. Does stable treatment with sodium oxybate have an effect on OSLER sleep latency?

—

Secondary

Measure	Time frame
NVT	—

Countries

Netherlands

Outcome results