Clinical trial NCT05321355: Mainz Register of Patients With Sleep Disorders
Official title: Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disorder
Sleep Disorder Parasomnia
Narcolepsy
Sleep Apnea
Insomnia
Somnambulism
Idiopathic Hypersomnia
Restless Legs Syndrome
REM Behavior Disorder
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))
timeFrame: 3 months
measure: European Quality of Life 5 dimensions Index (EQ 5D Index)
timeFrame: 3 months
measure: Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months
timeFrame: 6 months
measure: European Quality of Life 5 dimensions Index (EQ 5D Index)
timeFrame: 6 months
Secondary outcomes:
measure: Multidimensional Fatigue Inventory
timeFrame: 3 months
measure: Multidimensional Fatigue Inventory
timeFrame: 6 months
measure: Beck Depression Inventory II
timeFrame: 6 months
measure: Beck Depression Inventory II
timeFrame: 12 months
measure: Resilience Scale 13
timeFrame: 6 months
measure: Resilience Scale 13
timeFrame: 12 months
measure: European Quality of Life visual analogue scale (EQ-VAS)
timeFrame: 6 months
measure: European Quality of Life visual analogue scale (EQ-VAS)
timeFrame: 12 months
measure: Ullanlinna Narcolepsy Scale (UNS)
timeFrame: 3 months
measure: Ullanlinna Narcolepsy Scale (UNS)
timeFrame: 6 months
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 6 months
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 months
measure: Berlin Social Support Scales (BSSS)
timeFrame: 6 months
measure: Berlin Social Support Scales (BSSS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Mainz Comprehensive Epilepsy and Sleep Medicine Center
state: Rheinland-Pfalz
Study officials:
References: