Mainz Register of Patients With Sleep Disorders

Study Overview
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Brief Summary
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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
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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

Official Title
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Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)

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

Intervention / Treatment
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* Device: Implantation of vagus nerve stimulation according to clinical indication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with narcolepsy treated with vagus nerve stimulation<br>Patient with narcolepsy treated with vagus nerve stimulation | Device: Implantation of vagus nerve stimulation according to clinical indication<br>* no interventions, only observation<br>|
| Patient without narcolepsy treated with vagus nerve stimulation<br>Patient without narcolepsy treated with vagus nerve stimulation | Device: Implantation of vagus nerve stimulation according to clinical indication<br>* no interventions, only observation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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)) | 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 6 months | 
| Beck Depression Inventory II | Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63) | 6 months | 
| Beck Depression Inventory II | Beck Depression Inventory II: higher scores correspond to more severe depression (range | 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 | 6 months | 
| Resilience Scale 13 | Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low | 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) | 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) | 12 months | 
| Ullanlinna Narcolepsy Scale (UNS) | scale to identify the burden of narcolepsy | 3 months | 
| Ullanlinna Narcolepsy Scale (UNS) | scale to identify the burden of narcolepsy | 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) | 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) | 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 | 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 | 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 | 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 | 12 months |