Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy.
Yaroslav Winter, Christina Lang, Ulf Kallweit...
https://pubmed.ncbi.nlm.nih.gov/37839272Actively Recruiting
Led by Johannes Gutenberg University Mainz · Updated on 2022-09-15
500
Participants Needed
1
Research Sites
N/A
Total Duration
This observational study focuses on patients with sleep disorders treated at the Mainz Comprehensive Epilepsy and Sleep Medicine Center. It aims to understand the course of these diseases and their impact on quality of life by collecting both retrospective clinical data and prospective quality of life information. The study includes various sleep conditions such as narcolepsy, sleep apnea, insomnia, restless legs syndrome, and others. Participants include patients with narcolepsy and other neurological sleep disorders, some of whom may be treated with vagus nerve stimulation. The study observes patients with and without narcolepsy who have received this device treatment but does not involve any additional interventions. Data collection covers clinical history, prior medication use, and disease severity. During the study, patients will complete assessments measuring daytime sleepiness, quality of life, fatigue, depression, resilience, sleep quality, and social support at multiple time points including 3, 6, and 12 months. These evaluations use tools such as the Epworth Sleepiness Scale, Beck Depression Inventory, and Pittsburgh Sleep Quality Index. The study monitors these outcomes to better understand the disease progression and patient experience over time.
CONDITIONS
Mainz Register of Patients With Sleep Disorders
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants undergo implantation of vagus nerve stimulation according to clinical indication, followed by observation.
Visits at 3, 6, and 12 months for assessments
Total: 1 location
1
Mainz Comprehensive Epilepsy and Sleep Medicine Center
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Yaroslav Winter, Christina Lang, Ulf Kallweit...
https://pubmed.ncbi.nlm.nih.gov/37839272