hypersomnieën hypersomnia narcolepsy
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: 1. Narcolepsy type 1 based on ICSD-3 criteria. 2. *18 and
Exclusion criteria
Exclusion criteria: Patients and healthy controls: 1. Smoking. 2. Renal, hepatic or endocrine disease. 3. Previous use of sodium oxybate. 4. Use of medication known to influence glucose and/or lipid metabolism or brown adiposue tissue activity (e.g. *-adrenergic receptor blockers). 5. Participation in an intensive weight-loss program or vigorous exercise program during the year before the start of the study. 6. Contraindications for sodium oxybate treatment. 7. Contraindications for undergoing an MRI scan: - Presence of non-MR safe metal implants or objects in the body. - Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid, large recent tattoos. - Claustrophobia - Tinnitus or hyperacusis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cold-induced BAT volume and activity: measured by individualized cooling followed by 18F-FDG PET-CT scan in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Resting energy expenditure: measured by indirect calorimetry in healthy controls and in narcolepsy type 1 patients before, after 1 day and after 3 weeks of SXB treatment. - Skin temperature: measured by wireless iButtons in healthy controls and in narcolepsy type 1 patients before, after 1 day and after 3 weeks of SXB treatment. - Thermoneutral and cold-induced lipoprotein dynamics in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment. - Fat/lean mass loss: measured by bioelectrical impedance analysis measurement. - Thermoneutral BAT volume and fat fraction: measured by MRI scan in thermoneutral condition in healthy controls and in narcolepsy type 1 patients before and after 3 weeks of SXB treatment. | — |
Countries
Netherlands