MAINZ-SLEEPREG: Mainz Register of Patients With Sleep Disorders

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05321355

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder Sleep Disorder Parasomnia Narcolepsy Sleep Apnea Insomnia Somnambulism Idiopathic Hypersomnia Restless Legs Syndrome REM Behavior Disorder	Other: no interventions, only observation

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jan 31, 2030

Anticipated Study Completion Date :

Jan 31, 2030

Outcome Measures

Primary Outcome Measures

Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 3 months [3 months]
EDS measure by ESS at the follow-up after 3 months
European Quality of Life 5 dimensions Index (EQ 5D Index) [3 months]
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)
Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months [6 months]
EDS measure by ESS at the follow-up after 6 months
European Quality of Life 5 dimensions Index (EQ 5D Index) [6 months]
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)

Secondary Outcome Measures

Multidimensional Fatigue Inventory [3 months]
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Multidimensional Fatigue Inventory [6 months]
Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Beck Depression Inventory II [6 months]
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Beck Depression Inventory II [12 months]
Beck Depression Inventory II: higher scores correspond to more severe depression (range
Resilience Scale 13 [6 months]
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
Resilience Scale 13 [12 months]
Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low
European Quality of Life visual analogue scale (EQ-VAS) [6 months]
European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)
European Quality of Life visual analogue scale (EQ-VAS) [12 months]
European Quality of Life visual analogue scale (EQ-VAS) (ranges from 0 to 100, where 0 is the worst anf 100 the best state)
Ullanlinna Narcolepsy Scale (UNS) [3 months]
scale to identify the burden of narcolepsy
Ullanlinna Narcolepsy Scale (UNS) [6 months]
scale to identify the burden of narcolepsy
World Health Organization Quality of Life-BREF (WHOQOL-BREF) [6 months]
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)
World Health Organization Quality of Life-BREF (WHOQOL-BREF) [12 months]
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)
Pittsburgh Sleep Quality Index [6 months]
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
Pittsburgh Sleep Quality Index [12 months]
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
Berlin Social Support Scales (BSSS) [6 months]
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
Berlin Social Support Scales (BSSS) [12 months]
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