Idiopathic Hypersomnia, Insomnia, Narcolepsy, REM Behavior Disorder, Restless Legs Syndrome, Sleep Apnea, Sleep Disorder, Sleep Disorder Parasomnia, Somnambulism
Conditions
Brief summary
Prospective longitudinal observational registry study of all patients with sleep disorders treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.
Detailed description
Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively
Interventions
DEVICEImplantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Sponsors
Johannes Gutenberg University Mainz
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* patients with narcolepsy * patients with other neurological sleep disorders
Exclusion criteria
* patients aged \<18 years * patients who cannot provide informed consent and don't have a legal guardian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness)) | 3 months | EDS measure by ESS at the follow-up after 3 months |
| European Quality of Life 5 dimensions Index (EQ 5D Index) | 3 months | health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state) |
| Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months | 6 months | EDS measure by ESS at the follow-up after 6 months (rating from 0 (no sleepiness) to 24 (severe sleepiness)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Quality of Life visual analogue scale (EQ-VAS) | 6 months | European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state) |
| Ullanlinna Narcolepsy Scale (UNS) | 3 months | scale to identify the burden of narcolepsy |
| Multidimensional Fatigue Inventory | 3 months | Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores |
| Pittsburgh Sleep Quality Index | 6 months | Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality |
| Berlin Social Support Scales (BSSS) | 6 months | Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support |
| World Health Organization Quality of Life-BREF (WHOQOL-BREF) | 6 months | World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life) |
| Beck Depression Inventory II | 6 months | Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63) |
| Resilience Scale 13 | 6 months | Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience |
Countries
Germany
Outcome results
None listed