Sleep DisorderMAINZ-SLEEPREGNCT05321355
Mainz Register of Patients With Sleep Disorders
An observational study of Sleep Disorder and Sleep Disorder Parasomnia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Sleep Disorder, Sleep Disorder Parasomnia, Narcolepsy
- What is being tested?
- Implantation of vagus nerve stimulation according to clinical indication
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 31 Jan 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
Who may be able to join
- patients with narcolepsy
- patients with other neurological sleep disorders
Who cannot join
- patients aged <18 years
- patients who cannot provide informed consent and don't have a legal guardian
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Mainz Comprehensive Epilepsy and Sleep Medicine Center
Mainz, Rhineland-Palatinate, 55131
Winter Yaroslav, MD, MSc, +496131172234, yaroslav.winter@unimedizin-mainz.de
About this study
Official title: 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.
Read the 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
- Conditions
- Sleep Disorder, Sleep Disorder Parasomnia, Narcolepsy, Sleep Apnea, Insomnia, Somnambulism
- Being tested
- Implantation of vagus nerve stimulation according to clinical indication
- Medical subject headings
- Sleep Wake Disorders, Parasomnias, Narcolepsy, Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders, Somnambulism, Idiopathic Hypersomnia, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of vagus nerve stimulation according to clinical indicationDevice
no interventions, only observation
| Study group | Role | What they receive |
|---|---|---|
| Patient with narcolepsy treated with vagus nerve stimulation | Patient with narcolepsy treated with vagus nerve stimulation Receives: Device: Implantation of vagus nerve stimulation according to clinical indication | |
| Patient without narcolepsy treated with vagus nerve stimulation | Patient without narcolepsy treated with vagus nerve stimulation Receives: Device: Implantation of vagus nerve stimulation according to clinical indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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))
Measured: 6 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)
Measured: 6 months
Secondary outcomes (16)
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
Measured: 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
Measured: 6 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Measured: 6 months
Beck Depression Inventory II
Beck Depression Inventory II: higher scores correspond to more severe depression (range
Measured: 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
Measured: 6 months
Resilience Scale 13
Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low
Measured: 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)
Measured: 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)
Measured: 12 months
Ullanlinna Narcolepsy Scale (UNS)
scale to identify the burden of narcolepsy
Measured: 3 months
Ullanlinna Narcolepsy Scale (UNS)
scale to identify the burden of narcolepsy
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 12 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yaroslav Winter, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321355
- Sponsor's protocol ID
- MAINZ-SLEEPREG
- Acronym
- MAINZ-SLEEPREG
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Winter Y, Lang C, Kallweit U, Apel D, Fleischer V, Ellwardt E, Groppa S. Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy. Sleep Med. 2023 Dec;112:116-121. doi: 10.1016/j.sleep.2023.10.005. Epub 2023 Oct 9.
PubMed 37839272
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Disease Course and Quality of Life in Patients With Sleep Disorders (Mainz Sleep Registry)
- ClinicalTrials.gov ID
- NCT05321355
- Acronym / sponsor ID
- MAINZ-SLEEPREG / MAINZ-SLEEPREG
- Conditions
- Sleep Disorder, Sleep Disorder Parasomnia, Narcolepsy, Sleep Apnea, Insomnia, Somnambulism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with narcolepsy treated with vagus nerve stimulation | – | Device: Implantation of vagus nerve stimulation according to clinical indicationPatient with narcolepsy treated with vagus nerve stimulation |
| Patient without narcolepsy treated with vagus nerve stimulation | – | Device: Implantation of vagus nerve stimulation according to clinical indicationPatient without narcolepsy treated with vagus nerve stimulation |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center
Key inclusion criteria (2 listed)
- patients with narcolepsy
- patients with other neurological sleep disorders
Key exclusion criteria (2 listed)
- patients aged <18 years
- patients who cannot provide informed consent and don't have a legal guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of vagus nerve stimulation according to clinical indicationno interventions, only observation | Device | Patient with narcolepsy treated with vagus nerve stimulation, Patient without narcolepsy treated with vagus nerve stimulation |
Primary outcome
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
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)
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))
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)
16 secondary outcomes
Multidimensional Fatigue Inventory
Time frame: 3 months
Multidimensional Fatigue Inventory
Time frame: 6 months
Beck Depression Inventory II
Time frame: 6 months
Beck Depression Inventory II
Time frame: 12 months
Resilience Scale 13
Time frame: 6 months
Resilience Scale 13
Time frame: 12 months
European Quality of Life visual analogue scale (EQ-VAS)
Time frame: 6 months
European Quality of Life visual analogue scale (EQ-VAS)
Time frame: 12 months
Ullanlinna Narcolepsy Scale (UNS)
Time frame: 3 months
Ullanlinna Narcolepsy Scale (UNS)
Time frame: 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 6 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: 12 months
Pittsburgh Sleep Quality Index
Time frame: 6 months
Pittsburgh Sleep Quality Index
Time frame: 12 months
Berlin Social Support Scales (BSSS)
Time frame: 6 months
Berlin Social Support Scales (BSSS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 37839272Winter Y, Lang C, Kallweit U, Apel D, Fleischer V, Ellwardt E, Groppa S. Pitolisant-supported bridging during drug holidays to deal with tolerance to modafinil in patients with narcolepsy. Sleep Med. 2023 Dec;112:116-121. doi: 10.1016/j.sleep.2023.10.005. Epub 2023 Oct 9.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mainz Comprehensive Epilepsy and Sleep Medicine Center
Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder and Sleep Disorder Parasomnia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05321355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.