Health TrialsbyHealthPanel

Mainz Register of Patients With Sleep Disorders

ConditionsSleep DisorderSleep Disorder ParasomniaNarcolepsySleep ApneaInsomniaSomnambulismIdiopathic HypersomniaRestless Legs SyndromeREM Behavior Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorJohannes Gutenberg University Mainz

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with narcolepsy

patients with other neurological sleep disorders

Disqualifiers

patients aged <18 years

patients who cannot provide informed consent and don't have a legal guardian

Trial population

All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Implantation of vagus nerve stimulation according to clinical indication

    Device

    no interventions, only observation

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Patient with narcolepsy treated with vagus nerve stimulation1 intervention
Group B: Patient without narcolepsy treated with vagus nerve stimulation1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 months
2

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)

Time frame
3 months
3

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))

Time frame
6 months
4

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)

Time frame
6 months

Secondary outcomes

1

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

Time frame
3 months
2

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

Time frame
6 months
3

Beck Depression Inventory II

Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)

Time frame
6 months
4

Beck Depression Inventory II

Beck Depression Inventory II: higher scores correspond to more severe depression (range

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johannes Gutenberg University Mainz

Lead sponsor

Source ClinicalTrials.gov
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