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Stress response in narcolepsy type 1

Stress response in narcolepsy type 1 - Stress response in NT1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53558
Enrollment
24
Registered
2022-10-12
Start date
2023-02-24
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Narcolepsy type 1

Interventions

The TSST-G is an effective stress intervention, where participants are instructed to give a public speech, followed by a mental arithmetic task, before a non-supportive jury while thinking they are

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Age 18-64 years. - For patient group: a diagnosis of narcolepsy type 1 following the ICSD-3 criteria.

Exclusion criteria

Exclusion criteria: - For control group: any sleep-wake disorder or use of sleep medication - Any other disease that may affect HPA activity - History of anxiety disorders, panic attacks, cardiac disease or hypertension, epilepsy or Cushing*s disease - Mental retardation - Current depressive disorder - Current use of antidepressants (not being low dose for cataplexy) - Present use of benzodiazepines or any hormonal treatment (other than oral contraceptives) - Pregnant or lactating - Smoking > 5 cigarettes a day - Excessive alcohol consumption (women >14, men >21 units a week) - Lack of fluency in the Dutch language or speech impairments - Experienced public speaker - Psychologist or study/specialisation psychology

Design outcomes

Primary

MeasureTime frame
Difference between patients with NT1 and matched controls in the mean plasma cortisol levels after stress exposure (T1), adjusted for baseline plasma cortisol level (T0).

Secondary

MeasureTime frame
- Differences between patients with NT1 and matched controls in the plasma cortisol levels after recovery (T2 and T3), adjusted for baseline plasma cortisol level (T0). - Differences between patients with NT1 and matched controls in their plasma ACTH levels after stress exposure (T1) and recovery (T2 and T3), adjusted for baseline ACTH levels (T0). - Differences between patients with NT1 and matched controls in HR during all time points of the experiment. - Differences in subjectively experienced stress between patients with NT1 and matched controls at all time points of the experiment. - Differences between patients with NT1 and matched controls in the association between objective and subjective stress parameters, and their relationship with any of the background variables, during all time points of the experiment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)