Parkinson DiseasePDMCI-TSNCT04736017
Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment
A study testing TSB Axo in people with Parkinson Disease and Mild Cognitive Impairment, run by University of Zurich at 1 site in Switzerland.
Trial summary
The study aims to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. Patients will be randomized to two groups: Group 1 will first be treated with auditory stimulation for two weeks and then - after a washout period - switched to two weeks of sham… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment
- What is being tested?
- TSB Axo
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2021to 31 Mar 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD: Diagnosis of PD along international criteria, with mild to moderate disease severity (Hoehn and Yahr scale, stages ll-lll)
- PD: Ability to apply the intervention for the duration of study
- MCI: Diagnosis of MCI along international criteria, with a predominant amnestic presentation (single- or multi-domain amnestic MCI)
- MCI: Presence of a cohabitant person who could assist with the application
- MCI: Ability to apply the intervention for the duration of study, with assistance of co-habitant if needed
- PD and MCI:
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- Age above 18 years
- Informed consent as documented by signature
- Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
- Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
- Dosing of dopaminergic, cholinergic, and other PD or MCI medication must have been stable for at least 14 days prior to start of the first intervention
- Negative pregnancy test during screening (except in women who are surgically sterilized/hysterectomized or postmenopausal for longer than 1 year)
Who cannot join
- PD: Presence of neurologic, psychiatric, or sleep disorders (others than associated with PD)
- PD: Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
- PD: Cognitive impairment (Montréal Cognitive Assessment [MoCA] <24)
- MCI: Present diagnosis of a neurological (other than MCI) or interfering psychiatric disease or sleep disorder (e.g. sleep apnoea syndrome, restless legs syndrome)
- PD and MCI:
- Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
Show all 22Show fewer
- Regular use of the following drugs: Benzodiazepines and other central nervous system (CNS)-depressant substances, melatonin and other sleep inducing substances, approved drugs for Alzheimer-type dementia (acetylcholine-esterase inhibitor, memantine)
- Inability to hear the tones produced by the TSB Axo
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- Known or suspected drug- or medication abuse
- Known or suspected non-compliance
- Participation in another study with investigational drug or investigational medical devices within the 30 days preceding and during the present study
- Previous enrolment in the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Shift work (work during the night)
- Travelling more than 2 time zones in the last month before intervention starts or during intervention (start of intervention will be adapted to fit with this criteria)
- Substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day)
- High caffeine consumption (> 5 servings/day; including coffee, energy drink)
- Implanted deep brain stimulation electrodes
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Neurology department
Zurich, 8050
Jana Horlacher, MD, +41432535022, jana.horlacher@usz.ch
Angelina Maric, PhD, +41442558615, Angelina.maric@usz.ch
About this study
Official title: Assessing Effects of Auditory Slow Wave Enhancement on Symptoms and Biomarker Levels in Parkinson Disease and Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo- Controlled Crossover Study
The study aims to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. Patients will be randomized to two groups: Group 1 will first be treated with auditory stimulation for two weeks and then - after a washout period - switched to two weeks of sham stimulation. Group 2 will first receive sham stimulation for two weeks and then - after a washout period - switch to two weeks of auditory stimulation treatment. The washout period in between will be 2-4 weeks.
Read the detailed description
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. The screening phase includes entry questionnaires about inclusion/exclusion criteria, sleep quality, chronotype, and handedness, and 1-4 screening nights at home with the TSB Axo, to allow for stimulation optimization. One of the screening nights will be extended to screen for sleep apnea and periodic limb movements during sleep using an ambulatory screening device. Upon final inclusion, 24 PD and 24 MCI patients will be enrolled in the study for an overall period of 6-8 weeks (not including screening phase). Patients will receive 2 weeks of auditory SWS enhancement and 2 weeks of sham stimulation (only device application, no tones played) in a counter-balanced cross-over design, with a 2-4 week washout period during cross-over. Study visits will be performed immediately before and after each intervention period, i.e. after 2 weeks of auditory stimulation or sham stimulation, respectively. Study visits will include standardized clinical examinations, symptom questionnaires, blood sampling after intervention and screening for adverse events by a study physician. Study visits will take place at the Department of Neurology, University Hospital Zurich.
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Being tested
- TSB Axo
- Keywords
- Parkinson Disease, Mild Cognitive Impairment, Excessive Daytime Sleepiness, Sleep, Slow wave sleep, Auditory enhancement, Neurodegeneration, Cognition
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Disorders of Excessive Somnolence, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSB AxoDevice
The TSB Axo is a wearable biosignal recording device combined with an auditory stimulation. The device consists of pre-gelled biosignal electrodes, headphones integrated in a headband, and a biosignal processing module.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | The device records EEG and other biosignals throughout the night and scans these signals for slow waves associated with deep Non-Rapid Eye Movement (NREM) sleep. Upon recognition of such slow waves and fulfilment of other criteria, a tone is played via the headphones to stimulate and enhance slow waves without waking up the patient. Receives: Device: TSB Axo |
| Sham | Sham comparator | Playing no tones during NREM sleep but wearing the device and recording the biosignals over a period of 2 weeks, every night. Receives: Device: TSB Axo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in objective EDS
Difference in objective excessive daytime sleepiness (EDS), measured with Multiple Sleep Latency Test (MSLT; minutes), in Parkinson patients
Measured: assessed after each intervention (day 15 of each intervention)
Difference in verbal episodic memory performance
Difference in verbal episodic memory performance, measured with the Hopkins Verbal Learning Test (HVLT; score ranges from 0 to 12, higher scores indicate better performance) delayed recall, in Mild Cognitive Impairment patients
Measured: assessed after each intervention (day 15 of each intervention)
Secondary outcomes (20)
Subjective EDS
Change in subjective excessive daytime sleepiness (EDS), measured with the Epworth Sleepiness Scale (ESS; score ranges from 0 to 24, higher scores indicate greater EDS)
Measured: assessed before and after each intervention (day 1 and 15 of each intervention)
Sustained attention
Sustained attention, measured with the Sustained Attention to Response Task (SART)
Measured: assessed after each intervention (day 15 of each intervention)
Vigilance
Vigilance, measured with the Psychomotor Vigilance Task (PVT)
Measured: assessed after each intervention (day 15 of each intervention)
Subjective nocturnal sleep quality
Subjective nocturnal sleep quality, measured with the Parkinson's Disease Sleep Scale -2 (PDSS-2; score ranges from 0 to 60, higher scores indicate worse sleep quality) in PD patients and Pittsburgh Sleep Quality Index (PSQI; score ranges from 0 to 21, higher scores indicate worse sleep quality) in MCI patients
Measured: assessed before and after each intervention (day 1 and 15 of each intervention)
Executive Function and attention
Executive function (mental flexibility, verbal fluency, motor programming, sensitivity to interference, working memory, psychomotor processing speed), measured with the Trail Making Test (TMT; in seconds) B/A, the Regensburger Wortflüssigkeitstest (RWT; phonematic and semantic verbal fluency; in word count), the Luria's motor sequence test, the Victoria Stroop Task, the 2-back task, and the TMT A
Measured: assessed after each intervention (day 15 of each intervention)
Plasma biomarkers
Plasma levels of protein accumulation (aSyn, beta-amyloid 40 and 42 [Aß40, Aß40], tau, phosphorylated tau [p-tau]), neurodegeneration (neurofilament light chain; NFL), and synaptic and inflammatory markers
Measured: assessed after each intervention (day 15 of each intervention)
Subjective sleep quality
Subjective sleep quality measured with a Visual Analog Scale (VAS) on a scale from very poor to very good
Measured: assessed every morning during the intervention period (days 1-15 of each intervention)
Subjective mood
Subjective mood during daytime measured with a Visual Analog Scale (VAS) on a scale from very poor to very good
Measured: assessed every evening during the intervention period (days 1-14 of each intervention)
Subjective momentary sleepiness
Subjective momentary sleepiness measured with Karolinska Sleepiness Scale (KSS; score ranges from 1 to 9, higher scores indicate greater momentary sleepiness)
Measured: assessed every evening during the intervention period (days 1-14 of each intervention)
Digital biomarkers
tapping behavior on tablet
Measured: assessed every day during the intervention (days 1-15 of each intervention)
Sleep intensity
Sleep intensity, represented by Slow Wave Activity/ Slow Wave Energy (SWA/SWE), calculated from EEG recordings obtained every night at home with a frontal EEG electrode of the TSB Axo
Measured: assessed continuously during the intervention period (days 1-15 of each intervention)
Depressive symptoms
Depressive symptoms, indicated by the Hospital Anxiety and Depression Scale (HADS; score ranges from 0 to 21, higher scores indicate more depressive symptoms), in MCI patients
Measured: assessed before and after each intervention (day 1 and 15 of each intervention)
Verbal episodic and visuospatial memory function
Verbal episodic and visuospatial memory function, measured with the Hopkins Verbal Learning Test (HVLT; score ranges from 0 to 12, higher scores indicate better performance), and Brief Visuospatial Memory Test (BVMT; score ranges from 0 to 12, higher scores indicate better performance), in MCI patients
Measured: assessed after each intervention (day 15 of each intervention)
Quality of life (VAS)
Quality of life, measured with a Visual Analog Scale (VAS) on a scale from very poor to very good, in Parkinson patients
Measured: assessed before and after each intervention (day 1 and 14, day 29 and 42)
Motor symptoms
Motor symptoms, assessed with the Unified Parkinson's Disease Rating Scale (UPDRS) lll remote version (on tablet; score ranges from 0 to 104, higher scores indicate worse motor symptoms), in Parkinson patients
Measured: assessed before and after each intervention, in the morning prior to dopaminergic medication intake (day 1 and 14 of each intervention)
Focused motor assessment
Assessment of hand/finger movements, in Parkinson patients
Measured: assessed on day 4 of each intervention
Overnight memory consolidation
Overnight memory consolidation, assessed with a word-pair task and finger tapping sequence test in PD and MCI patients
Measured: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration inhibitory control
Overnight restoration of inhibitory control, assessed with the Go/NoGo Task (GNG) in PD and MCI patients
Measured: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration working memory
Overnight restoration of the working memory, assessed by the 2-back task in PD and MCI patients
Measured: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration vigilance
Overnight restoration of vigilance, assessed by the Psychomotor Vigilance Test (PVT) in PD and MCI patients
Measured: assessed in the evening of day 13 and in the morning of day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomized, double-blind, sham-controlled cross-over trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelina Maric, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736017
- Sponsor's protocol ID
- PDMCI-TS
- Acronym
- PDMCI-TS
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effects of Auditory Slow Wave Enhancement on Symptoms and Biomarker Levels in Parkinson Disease and Mild Cognitive Impairment: A Randomized, Double-Blind and Placebo- Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT04736017
- Acronym / sponsor ID
- PDMCI-TS / PDMCI-TS
- Conditions
- Parkinson Disease, Mild Cognitive Impairment
- Keywords
- Parkinson Disease, Mild Cognitive Impairment, Excessive Daytime Sleepiness, Sleep, Slow wave sleep, Auditory enhancement, Neurodegeneration, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 3 Feb 2021 (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 study aims to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. Patients will be randomized to two groups: Group 1 will first be treated with auditory stimulation for two weeks and then - after a washout period - switched to two weeks of sham stimulation. Group 2 will first receive sham stimulation for two weeks and then - after a washout period - switch to two weeks of auditory stimulation treatment. The washout period in between will be 2-4 weeks.
Detailed description
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy of auditory slow-wave sleep (SWS) enhancement in PD patients and patients with amnestic MCI. The screening phase includes entry questionnaires about inclusion/exclusion criteria, sleep quality, chronotype, and handedness, and 1-4 screening nights at home with the TSB Axo, to allow for stimulation optimization. One of the screening nights will be extended to screen for sleep apnea and periodic limb movements during sleep using an ambulatory screening device. Upon final inclusion, 24 PD and 24 MCI patients will be enrolled in the study for an overall period of 6-8 weeks (not including screening phase). Patients will receive 2 weeks of auditory SWS enhancement and 2 weeks of sham stimulation (only device application, no tones played) in a counter-balanced cross-over design, with a 2-4 week washout period during cross-over. Study visits will be performed immediately before and after each intervention period, i.e. after 2 weeks of auditory stimulation or sham stimulation, respectively. Study visits will include standardized clinical examinations, symptom questionnaires, blood sampling after intervention and screening for adverse events by a study physician. Study visits will take place at the Department of Neurology, University Hospital Zurich.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, double-blind, sham-controlled cross-over trial.
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Device: TSB AxoThe device records EEG and other biosignals throughout the night and scans these signals for slow waves associated with deep Non-Rapid Eye Movement (NREM) sleep. Upon recognition of such slow waves and fulfilment of other criteria, a tone is played via the headphones to stimulate and enhance slow waves without waking up the patient. |
| Sham | Sham comparator | Device: TSB AxoPlaying no tones during NREM sleep but wearing the device and recording the biosignals over a period of 2 weeks, every night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PD: Diagnosis of PD along international criteria, with mild to moderate disease severity (Hoehn and Yahr scale, stages ll-lll)
- PD: Ability to apply the intervention for the duration of study
- MCI: Diagnosis of MCI along international criteria, with a predominant amnestic presentation (single- or multi-domain amnestic MCI)
- MCI: Presence of a cohabitant person who could assist with the application
- MCI: Ability to apply the intervention for the duration of study, with assistance of co-habitant if needed
Key exclusion criteria (22 listed)
- PD: Presence of neurologic, psychiatric, or sleep disorders (others than associated with PD)
- PD: Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
- PD: Cognitive impairment (Montréal Cognitive Assessment [MoCA] <24)
- MCI: Present diagnosis of a neurological (other than MCI) or interfering psychiatric disease or sleep disorder (e.g. sleep apnoea syndrome, restless legs syndrome)
- Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
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 |
|---|---|---|
| TSB AxoThe TSB Axo is a wearable biosignal recording device combined with an auditory stimulation. The device consists of pre-gelled biosignal electrodes, headphones integrated in a headband, and a biosignal processing module. | Device | Sham, Verum |
Primary outcome
Difference in objective EDS
Time frame: assessed after each intervention (day 15 of each intervention)
Difference in objective excessive daytime sleepiness (EDS), measured with Multiple Sleep Latency Test (MSLT; minutes), in Parkinson patients
Difference in verbal episodic memory performance
Time frame: assessed after each intervention (day 15 of each intervention)
Difference in verbal episodic memory performance, measured with the Hopkins Verbal Learning Test (HVLT; score ranges from 0 to 12, higher scores indicate better performance) delayed recall, in Mild Cognitive Impairment patients
20 secondary outcomes
Subjective EDS
Time frame: assessed before and after each intervention (day 1 and 15 of each intervention)
Sustained attention
Time frame: assessed after each intervention (day 15 of each intervention)
Vigilance
Time frame: assessed after each intervention (day 15 of each intervention)
Subjective nocturnal sleep quality
Time frame: assessed before and after each intervention (day 1 and 15 of each intervention)
Executive Function and attention
Time frame: assessed after each intervention (day 15 of each intervention)
Plasma biomarkers
Time frame: assessed after each intervention (day 15 of each intervention)
Subjective sleep quality
Time frame: assessed every morning during the intervention period (days 1-15 of each intervention)
Subjective mood
Time frame: assessed every evening during the intervention period (days 1-14 of each intervention)
Subjective momentary sleepiness
Time frame: assessed every evening during the intervention period (days 1-14 of each intervention)
Digital biomarkers
Time frame: assessed every day during the intervention (days 1-15 of each intervention)
Sleep intensity
Time frame: assessed continuously during the intervention period (days 1-15 of each intervention)
Depressive symptoms
Time frame: assessed before and after each intervention (day 1 and 15 of each intervention)
Verbal episodic and visuospatial memory function
Time frame: assessed after each intervention (day 15 of each intervention)
Quality of life (VAS)
Time frame: assessed before and after each intervention (day 1 and 14, day 29 and 42)
Motor symptoms
Time frame: assessed before and after each intervention, in the morning prior to dopaminergic medication intake (day 1 and 14 of each intervention)
Focused motor assessment
Time frame: assessed on day 4 of each intervention
Overnight memory consolidation
Time frame: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration inhibitory control
Time frame: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration working memory
Time frame: assessed in the evening of day 13 and in the morning of day 14
Overnight restoration vigilance
Time frame: assessed in the evening of day 13 and in the morning of day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
Angelina Maric, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSB Axo in people with Parkinson Disease and Mild Cognitive Impairment, 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 12 inclusion and 22 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 15 Nov 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 Jana Horlacher, MD (+41432535022, jana.horlacher@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in objective EDS (time frame: assessed after each intervention (day 15 of each intervention)). The study lists 2 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 15 Nov 2022.