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NCT Number: NCT05321355

Mainz Register of Patients With Sleep Disorders

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.

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Key information

Conditions

Sleep Disorder Apnea Disorders of Excessive Somnolence Dyssomnias Idiopathic Hypersomnia Insomnia Mental Disorders Narcolepsy Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms REM Behavior Disorder REM Sleep Behavior Disorder REM Sleep Parasomnias Respiration Disorders Respiratory Tract Diseases Restless Legs Syndrome Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Arousal Disorders Sleep Disorder Parasomnia Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Somnambulism

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mainz Comprehensive Epilepsy and Sleep Medicine Center

Mainz, Rhineland-Palatinate, 55131, Germany

Location status: Recruiting

Location contact

Winter Yaroslav, MD, MSc

CONTACT

[email protected]

+496131172234

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of vagus nerve stimulation according to clinical indication

Device

no interventions, only observation

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))

    Time frame: 3 months

    EDS measure by ESS at the follow-up after 3 months

  2. European Quality of Life 5 dimensions Index (EQ 5D Index)

    Time frame: 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)

  3. Excessive daytime sleepiness (EDS) as measure by Epworth Sleepiness Scale (ESS) after 6 months

    Time frame: 6 months

    EDS measure by ESS at the follow-up after 6 months (rating from 0 (no sleepiness) to 24 (severe sleepiness))

  4. European Quality of Life 5 dimensions Index (EQ 5D Index)

    Time frame: 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 outcomes

  1. Multidimensional Fatigue Inventory

    Time frame: 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

  2. Multidimensional Fatigue Inventory

    Time frame: 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

  3. Beck Depression Inventory II

    Time frame: 6 months

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

  4. Beck Depression Inventory II

    Time frame: 12 months

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

  5. Resilience Scale 13

    Time frame: 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

  6. Resilience Scale 13

    Time frame: 12 months

    Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low

  7. European Quality of Life visual analogue scale (EQ-VAS)

    Time frame: 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)

  8. European Quality of Life visual analogue scale (EQ-VAS)

    Time frame: 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)

  9. Ullanlinna Narcolepsy Scale (UNS)

    Time frame: 3 months

    scale to identify the burden of narcolepsy

  10. Ullanlinna Narcolepsy Scale (UNS)

    Time frame: 6 months

    scale to identify the burden of narcolepsy

  11. World Health Organization Quality of Life-BREF (WHOQOL-BREF)

    Time frame: 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)

  12. World Health Organization Quality of Life-BREF (WHOQOL-BREF)

    Time frame: 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)

  13. Pittsburgh Sleep Quality Index

    Time frame: 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

  14. Pittsburgh Sleep Quality Index

    Time frame: 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

  15. Berlin Social Support Scales (BSSS)

    Time frame: 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

  16. Berlin Social Support Scales (BSSS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: MAINZ-SLEEPREG

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 11, 2022
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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