NCT05321355

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2022Jan 2030

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

8 years

First QC Date

April 4, 2022

Last Update Submit

September 11, 2022

Conditions

Sleep DisorderSleep Disorder ParasomniaNarcolepsySleep ApneaInsomniaSomnambulismIdiopathic HypersomniaRestless Legs SyndromeREM Behavior Disorder

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (16)

  • Multidimensional Fatigue Inventory

    3 months

  • Multidimensional Fatigue Inventory

    6 months

  • Beck Depression Inventory II

    6 months

  • Beck Depression Inventory II

    12 months

  • Resilience Scale 13

    6 months

  • +11 more secondary outcomes

Study Arms (2)

Patient with narcolepsy treated with vagus nerve stimulation

Patient with narcolepsy treated with vagus nerve stimulation

Device: Implantation of vagus nerve stimulation according to clinical indication

Patient without narcolepsy treated with vagus nerve stimulation

Patient without narcolepsy treated with vagus nerve stimulation

Device: Implantation of vagus nerve stimulation according to clinical indication

Interventions

Implantation of vagus nerve stimulation according to clinical indicationDEVICE

no interventions, only observation

Patient with narcolepsy treated with vagus nerve stimulationPatient without narcolepsy treated with vagus nerve stimulation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

You may qualify if:

  • patients with narcolepsy
  • patients with other neurological sleep disorders

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mainz Comprehensive Epilepsy and Sleep Medicine Center

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37839272DERIVED

MeSH Terms

Conditions

Sleep Wake DisordersParasomniasNarcolepsySleep Apnea SyndromesSleep Initiation and Maintenance DisordersSomnambulismIdiopathic HypersomniaRestless Legs SyndromeREM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDisorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasApneaRespiration DisordersRespiratory Tract DiseasesSleep Arousal DisordersREM Sleep Parasomnias

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Mainz Comprehensive Epilepsy and Sleep Medicine Center

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 11, 2022

Study Start

February 1, 2022

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

January 31, 2030

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations

DE(1)