Mainz Register of Patients With Sleep Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Implantation of vagus nerve stimulation according to clinical indication: no interventions, only observation

Study 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.

Eligibility

Primary outcome measure(s)

• 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))
• European Quality of Life 5 dimensions Index (EQ 5D Index) — 6 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)

Trial sites (1)

More Johannes Gutenberg University Mainz trials in Germany

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