Mainz Register of Patients With Sleep Disorders

Insomnia Clinical Trial

— MAINZ-SLEEPREG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05321355
• Other study ID #: MAINZ-SLEEPREG
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: January 31, 2030

Study information

• Verified date: September 2022
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 31, 2030
• Est. primary completion date: January 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Disorders of Excessive Somnolence
• Idiopathic Hypersomnia
• Insomnia
• Mental Disorders
• Narcolepsy
• Parasomnias
• REM Behavior Disorder
• REM Sleep Behavior Disorder
• Restless Legs Syndrome
• Sleep Apnea
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Implantation of vagus nerve stimulation according to clinical indication
no interventions, only observation

Locations

Country	Name	City	State
Germany	Mainz Comprehensive Epilepsy and Sleep Medicine Center	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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	3 months
Secondary	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	6 months
Secondary	Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)	6 months
Secondary	Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range	12 months
Secondary	Resilience Scale 13	Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience	6 months
Secondary	Resilience Scale 13	Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low	12 months
Secondary	European Quality of Life visual analogue scale (EQ-VAS)	European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)	6 months
Secondary	European Quality of Life visual analogue scale (EQ-VAS)	European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)	12 months
Secondary	Ullanlinna Narcolepsy Scale (UNS)	scale to identify the burden of narcolepsy	3 months
Secondary	Ullanlinna Narcolepsy Scale (UNS)	scale to identify the burden of narcolepsy	6 months
Secondary	World Health Organization Quality of Life-BREF (WHOQOL-BREF)	World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)	6 months
Secondary	World Health Organization Quality of Life-BREF (WHOQOL-BREF)	World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)	12 months
Secondary	Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality	6 months
Secondary	Pittsburgh Sleep Quality Index	Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality	12 months
Secondary	Berlin Social Support Scales (BSSS)	Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support	6 months
Secondary	Berlin Social Support Scales (BSSS)	Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support	12 months