Mainz Register of Patients With Sleep Disorders

NCT ID: NCT05321355

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2030-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with narcolepsy treated with vagus nerve stimulation

Patient with narcolepsy treated with vagus nerve stimulation

Implantation of vagus nerve stimulation according to clinical indication

Intervention Type DEVICE

no interventions, only observation

Patient without narcolepsy treated with vagus nerve stimulation

Patient without narcolepsy treated with vagus nerve stimulation

Implantation of vagus nerve stimulation according to clinical indication

Intervention Type DEVICE

no interventions, only observation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implantation of vagus nerve stimulation according to clinical indication

no interventions, only observation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Yaroslav Winter

Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mainz Comprehensive Epilepsy and Sleep Medicine Center

Mainz, Rhineland-Palatinate, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Winter Yaroslav, MD, MSc

Role: primary

+496131172234

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37839272 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAINZ-SLEEPREG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

EEG Studies of Ketamine General Anesthesia
NCT03553758 COMPLETED PHASE2/PHASE3
Brain Activity in Epilepsy
NCT05307146 RECRUITING NA
Acoustic Stimulation for Seizure Suppression
NCT03198494 ENROLLING_BY_INVITATION NA