An observational study in Sleep Disorder, Sleep Disorder Parasomnia and Narcolepsy, sponsored by Johannes Gutenberg University Mainz. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-09-15.
Sponsored by Johannes Gutenberg University Mainz · Observational
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.
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
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's planned enrollment of 500 is above the median of 120 across 197 observational studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Johannes Gutenberg University Mainz is the lead sponsor of 156 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient with narcolepsy treated with vagus nerve stimulation
Device: Implantation of vagus nerve stimulation according to clinical indication
Patient without narcolepsy treated with vagus nerve stimulation
Device: Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation
Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
EDS measure by ESS at the follow-up after 3 months
Time frame: 3 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
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)
Time frame: 3 months
Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months
EDS measure by ESS at the follow-up after 6 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
Time frame: 6 months
European Quality of Life 5 dimensions Index (EQ 5D Index)
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)
Time frame: 6 months
Multidimensional Fatigue Inventory
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Time frame: 3 months
Multidimensional Fatigue Inventory
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Time frame: 6 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Time frame: 6 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range
Time frame: 12 months
Resilience Scale 13
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
Time frame: 6 months
Resilience Scale 13
Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low
Time frame: 12 months
European Quality of Life visual analogue scale (EQ-VAS)
European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)
Time frame: 6 months
European Quality of Life visual analogue scale (EQ-VAS)
European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)
Time frame: 12 months
Ullanlinna Narcolepsy Scale (UNS)
scale to identify the burden of narcolepsy
Time frame: 3 months
Ullanlinna Narcolepsy Scale (UNS)
scale to identify the burden of narcolepsy
Time frame: 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
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)
Time frame: 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
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)
Time frame: 12 months
Pittsburgh Sleep Quality Index
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
Time frame: 6 months
Pittsburgh Sleep Quality Index
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
Time frame: 12 months
Berlin Social Support Scales (BSSS)
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
Time frame: 6 months
Berlin Social Support Scales (BSSS)
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
Time frame: 12 months
Plan to share: Yes
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Jan 2030, 95 months after the start.
Of 71 non-industry observational studies under Sleep Wake Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 95 months is above that.
Counting every sponsor, half of 82 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Johannes Gutenberg University Mainz →