Mainz Register of Patients With Sleep Disorders

Sponsor
Johannes Gutenberg University Mainz
Study ID
NCT05321355
Status
Recruiting
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Conditions

  • Idiopathic Hypersomnia
  • Insomnia
  • Narcolepsy
  • REM Behavior Disorder
  • Restless Legs Syndrome
  • Sleep Apnea
  • Sleep Disorder
  • Sleep Disorder Parasomnia
  • Somnambulism

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Implantation of vagus nerve stimulation according to clinical indication — DEVICE
    no interventions, only observation

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Sep 2022
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Patient with narcolepsy treated with vagus nerve stimulation
    Patient with narcolepsy treated with vagus nerve stimulation
  • Arm: Patient without narcolepsy treated with vagus nerve stimulation
    Patient without narcolepsy treated with vagus nerve stimulation

Primary Outcome Measure

Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness)) [ Time Frame: 3 months ]

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