Neurodegenerative DiseasesRFSNNCT05402488
Exploring the Recovery Function of Sleep in Neurodegeneration
A study testing Auditory stimulation in people with Neurodegenerative Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- Auditory stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Mar 2022to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria
- Age above 18 years
- In ambulant setting: ability to apply the ambulant EEG device for the duration of the study, either alone or with help of co-habitant if MoCA < 20
Who cannot join
- Failure to give informed consent
- Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
- Known or suspected non-compliance, drug- or medication abuse
- Inability to hear the tones to be applied during sleep in auditory stimulation experiments
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- Regular intake of drugs that may alter the relationship between sleep and outcome variables under investigation (opioids, benzodiazepines and z-drugs (nonbenzodiazepines)).
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- Clinically significant concomitant disease states
- Too high (disease) burden for patients
- Additional non-medical exclusion criteria may be defined for certain cognitive tasks (e.g. no glasses during experiments involving eye tracking)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Neurology department
Zurich, Canton of Zurich, 8091
Angelina Maric, PhD, +41 44 255 86 15, angelina.maric@usz.ch
About this study
Official title: Exploring the Recovery Function of Sleep in Neurodegeneration - an Observational Cross-Sectional Study
The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.
Read the detailed description
First, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. Healthy subjects will be assessed for procedure validation and reference purposes. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.
- Conditions
- Neurodegenerative Diseases
- Being tested
- Auditory stimulation
- Keywords
- Parkinson's Disease, Huntington's Disease, MCI, Neurodegenerative Diseases, Sleep, Auditory Stimulation
- Medical subject headings
- Neurodegenerative Diseases, Parkinson Disease, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory stimulationBehavioural
Auditory stimulation during sleep
| Study group | Role | What they receive |
|---|---|---|
| Verum stimulation | Experimental | Verum condition: Auditory stimulation during sleep Receives: Behavioral: Auditory stimulation |
| Sham stimulation | Sham comparator | Sham condition: Playing no tones during sleep but still recording brain activity (muted tones) Receives: Behavioral: Auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological markers of brain activity during sleep as measured with EEG
e.g. slow wave activity (SWA)
Measured: measured during 4 nights
Performance change in behavioral/cognitive tasks
e.g. reaction time
Measured: measured before and after 4 nights
Change in outcomes of subjective measures
e.g. sleepiness (scale from 1 to 10)
Measured: measured before and after 4 nights
Secondary outcomes (2)
Outcomes of other physiological measures during sleep
e.g. muscle activity (EMG)
Measured: measured during 4 nights
Outcomes of other physiological measures during behavioral tasks
e.g. pupil dilation
Measured: measured before and after 4 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start14 Mar 2022
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402488
- Sponsor's protocol ID
- RFSN
- Acronym
- RFSN
- Status last verified
- May 2022
- First submitted
- 21 Dec 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Recovery Function of Sleep in Neurodegeneration - an Observational Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05402488
- Acronym / sponsor ID
- RFSN / RFSN
- Conditions
- Neurodegenerative Diseases
- Keywords
- Parkinson's Disease, Huntington's Disease, MCI, Neurodegenerative Diseases, Sleep, Auditory Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Jun 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.
The overall objective of this study is to identify the best approach for assessing the recovery function of sleep in neurodegenerative diseases associated with abnormal protein aggregation with regard to the conception of future intervention studies. To this end, the investigators will follow an exploratory approach in a preferably broad data set collected in patients with neurodegenerative diseases associated with abnormal protein aggregation and in healthy humans.
Detailed description
First, the investigators want to assess the relationship between sleep parameters (e.g. sleep intensity) and behavioral/cognitive performance and subjective measures (e.g. sleep quality, mood, and sleepiness) in patients with neurodegenerative disorders associated with abnormal protein aggregation. Healthy subjects will be assessed for procedure validation and reference purposes. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum stimulation | Experimental | Behavioral: Auditory stimulationVerum condition: Auditory stimulation during sleep |
| Sham stimulation | Sham comparator | Behavioral: Auditory stimulationSham condition: Playing no tones during sleep but still recording brain activity (muted tones) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good general health or confirmed diagnosis of neurodegenerative disease associated with abnormal protein aggregation along international criteria
- Age above 18 years
- In ambulant setting: ability to apply the ambulant EEG device for the duration of the study, either alone or with help of co-habitant if MoCA < 20
Key exclusion criteria (9 listed)
- Failure to give informed consent
- Inability to follow the procedures of the study, e.g. due to language problems or cognitive deficits
- Known or suspected non-compliance, drug- or medication abuse
- Inability to hear the tones to be applied during sleep in auditory stimulation experiments
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
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 |
|---|---|---|
| Auditory stimulationAuditory stimulation during sleep | Behavioural | Sham stimulation, Verum stimulation |
Primary outcome
Electrophysiological markers of brain activity during sleep as measured with EEG
Time frame: measured during 4 nights
e.g. slow wave activity (SWA)
Performance change in behavioral/cognitive tasks
Time frame: measured before and after 4 nights
e.g. reaction time
Change in outcomes of subjective measures
Time frame: measured before and after 4 nights
e.g. sleepiness (scale from 1 to 10)
2 secondary outcomes
Outcomes of other physiological measures during sleep
Time frame: measured during 4 nights
Outcomes of other physiological measures during behavioral tasks
Time frame: measured before and after 4 nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory stimulation in people with Neurodegenerative Diseases, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 Jun 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelina Maric, Dr. phil. (+41 44 255 86 15, angelina.maric@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological markers of brain activity during sleep as measured with EEG (time frame: measured during 4 nights). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2022.