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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with narcolepsy treated with vagus nerve stimulation | Patient with narcolepsy treated with vagus nerve stimulation |
| |
| Patient without narcolepsy treated with vagus nerve stimulation | Patient without narcolepsy treated with vagus nerve stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of vagus nerve stimulation according to clinical indication | Device | no interventions, only observation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mainz Comprehensive Epilepsy and Sleep Medicine Center | Recruiting | Mainz | Rhineland-Palatinate | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37839272 | Derived | 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. |
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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 |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D020447 | Parasomnias |
| D009290 | Narcolepsy |
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013009 | Somnambulism |
| D020177 | Idiopathic Hypersomnia |
| D012148 | Restless Legs Syndrome |
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020921 | Sleep Arousal Disorders |
| D020923 | REM Sleep Parasomnias |
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