Actively Recruiting

Age: 18Years - 120Years
All Genders
ID05321355

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

Led by Johannes Gutenberg University Mainz · Updated on 2022-09-15

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Mainz Register of Patients With Sleep Disorders

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with narcolepsy
  • Patients with other neurological sleep disorders
Not Eligible

You will not qualify if you...

  • Patients aged <18 years
  • Patients who cannot provide informed consent and don't have a legal guardian

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

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

Trial Site Locations

Total: 1 location

1

Mainz Comprehensive Epilepsy and Sleep Medicine Center

Mainz, Rhineland-Palatinate, Germany, 55131

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

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/37839272