Mainz Register of Patients With Sleep Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of vagus nerve stimulation according to clinical indication.
- Who it may be relevant to
- Registry conditions: Sleep Disorder, Sleep Disorder Parasomnia, Narcolepsy, Sleep Apnea. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)
Overview
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
- Device Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Primary outcome measures
- 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]
- European Quality of Life 5 dimensions Index (EQ 5D Index) [Time frame: 3 months]
- Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months [Time frame: 6 months]
- European Quality of Life 5 dimensions Index (EQ 5D Index) [Time frame: 6 months]
Secondary outcome measures (12)
- Multidimensional Fatigue Inventory [Time frame: 3 months]
- Multidimensional Fatigue Inventory [Time frame: 6 months]
- Beck Depression Inventory II [Time frame: 6 months]
- Beck Depression Inventory II [Time frame: 12 months]
- Resilience Scale 13 [Time frame: 6 months]
- Resilience Scale 13 [Time frame: 12 months]
- European Quality of Life visual analogue scale (EQ-VAS) [Time frame: 6 months]
- European Quality of Life visual analogue scale (EQ-VAS) [Time frame: 12 months]
- Ullanlinna Narcolepsy Scale (UNS) [Time frame: 3 months]
- Ullanlinna Narcolepsy Scale (UNS) [Time frame: 6 months]
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [Time frame: 6 months]
- World Health Organization Quality of Life-BREF (WHOQOL-BREF) [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Germany · 1 center
- Mainz Comprehensive Epilepsy and Sleep Medicine Center — Mainz
Publications
- Winter Y, Lang C, Kallweit U, Apel D, Fleischer V, Ellwardt E, Groppa S. Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy. Sleep Med. 2023 Dec;112:116-121. doi: 10.1016/j.sleep.2023.10.005. Epub 2023 Oct 9. PMID 37839272
Identifiers
NCT: NCT05321355 · MAINZ-SLEEPREG