Mainz Register of Patients With Sleep Disorders (MAINZ-SLEEPREG)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Restless Legs Syndrome; Insomnia; Sleep Apnea; Narcolepsy; Idiopathic Hypersomnia; Somnambulism; Sleep Disorder Parasomnia; REM Behavior Disorder
• Intervention / Treatment: Device: Implantation of vagus nerve stimulation according to clinical indication

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

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Mainz Comprehensive Epilepsy and Sleep Medicine Center
      • Contact: Winter Yaroslav, MD, MSc; Phone Number: +496131172234; Email: yaroslav.winter@unimedizin-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with narcolepsy treated with vagus nerve stimulation	Device: Implantation of vagus nerve stimulation according to clinical indication; no interventions, only observation
Patient without narcolepsy treated with vagus nerve stimulation	Device: Implantation of vagus nerve stimulation according to clinical indication; no interventions, only observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)	6 months
Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range	12 months
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
Resilience Scale 13	Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low	12 months
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
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
Ullanlinna Narcolepsy Scale (UNS)	scale to identify the burden of narcolepsy	3 months
Ullanlinna Narcolepsy Scale (UNS)	scale to identify the burden of narcolepsy	6 months
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
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
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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 31, 2030
• Study Completion (Anticipated): January 31, 2030

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 11, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; REM Sleep Parasomnias; Sleep Arousal Disorders; Disease; Sleep Wake Disorders; Restless Legs Syndrome; Mental Disorders; Parasomnias; Disorders of Excessive Somnolence; REM Sleep Behavior Disorder; Narcolepsy; Somnambulism; Idiopathic Hypersomnia
• Other Study ID Numbers: MAINZ-SLEEPREG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No