Parkinson DiseaseNCT04589182
Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease
A study testing MHSL- SleepBand in people with Parkinson Disease and Mild Cognitive Impairment, run by Christian Baumann at 1 site in Switzerland.
Trial summary
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in Parkinson disease (PD) patients with disturbed nighttime sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment, Huntington Disease
- What is being tested?
- MHSL- SleepBand
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2020to 31 Oct 2022
- 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
- Informed consent as documented by signature
- Diagnosis of PD along international criteria with mild to moderate disease severity (Hoehn- Yahr (HY) stages ll-lll),
- Self-reported sleep problems and subjectively impaired sleep quality (PDSS-2 sleep quality subscale (items 1-3 and 14) ≥7)
- Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
- Ability to apply the intervention for the duration of study, either alone or with help of co-habitant
- Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
Show all 17Show fewer
- Dosing of dopaminergic and other PD treatment must have been stable for at least 14 days prior to the first intervention period
- Negative pregnancy test during screening (except in women who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year),
- Age above 18 years
- Informed Consent as documented by signature (see Informed Consent Form),
- Age above 18 years
- The diagnosis of MCI along international criteria or manifest HD (diagnosis of HD confirmed by genetic testing, patients above the age of 18 years, manifest HD, diagnostic confidence of 4)
- Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study,
- Stable regimen of therapeutic drugs for at least 2 weeks prior to the intervention,
- For HD patients: self-ambulatory
- Native German speaker or good understanding of German. Translation assistance will be accepted, if this will allow a nonnative German speaker to comprehensively follow the study protocol including all questionnaires
- Ability to apply the intervention for the duration of study, either alone or with help of co-habitant.
Who cannot join
- Known presence of neurologic (other than PD), psychiatric, or sleep disorders (others than associated with PD)
- Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
- Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
- The regular use of benzodiazepines and other central nervous system (CNS)-depressant substances, as well as melatonin and other sleep inducing substances
- Inability to hear the tones produced by the MHSL-SleepBand device
- Absence of slow-wave enhancement by auditory stimulation during the screening night
Show all 41Show fewer
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- Failure to give informed consent
- Known or suspected drug- or medication abuse
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
- Cognitive impairment (Montreal Cognitive Assessment - MoCA <24)
- Participation in another study with investigational drug 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)
- Planned medical intervention of substantial relevance, e.g. surgery, during intervention (routine assessments, e.g. check-ups will be allowed)
- 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. Please note that female patients who are surgically sterilized/hysterectomized or postmenopausal for longer than 1 year are not considered as being of child bearing potential.
- Pilot studies:
- MCI: Present diagnosis of neurologic (other than MCI), interfering psychiatric, or severe internal disease
- HD: Diagnosis of juvenile onset HD
- HD: History of co-morbid neurological conditions (e.g. multiple sclerosis or stroke), interfering psychiatric or cognitive disorders
- Severe medical conditions, such as renal insufficiency, liver failure or congestive heart failure
- Inability to hear the tones to be applied during sleep when awake
- Skin disorders/problems/allergies in face/ear area that could worsen with electrode application
- MCI: absence of a cohabitant who could assist with study applications and procedures
- Failure to give informed consent
- Known or suspected drug- or medication abuse
- Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits,
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- substance or alcohol abuse (i.e. > 0.5 l wine or 1 l beer per day),
- Planned medical intervention of substantial relevance, e.g. surgery, during intervention (routine assessments, e.g. check-ups will be allowed)
- 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. Please note that female patients who are surgically sterilized/hysterectomized or post-menopausal for longer than 1 year are not considered as being of child bearing potential.
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
Simon Schreiner, MD, +41 44 355 55 11, simon.schreiner@usz.ch
About this study
Official title: Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease: A Randomized, Double-Blind and Placebo-Controlled Crossover Study
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in Parkinson disease (PD) patients with disturbed nighttime sleep.
Additionally, the investigators will assess the feasibility and efficacy of auditory slow-wave sleep (SWS) enhancement in Mild Cognitive Impairment (MCI) and Huntington Disease (HD) patients in a pilot study.
Read the detailed description
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in PD patients with disturbed nighttime sleep. Patients will be randomized to 2 groups: Group 1 will first be treated with auditory stimulation for 3 nights and then - after a wash-out period of 4 nights - switched to 3 nights of sham stimulation. Group 2 will first receive sham-stimulation for 3 nights and then switch to 3 nights of auditory stimulation treatment. The wash-out period in between will be 4 nights. Patients and investigators assessing the outcomes will be blinded to the conditions. All interventions will take place at the patients' homes.
The pilot study is aimed at assessment of safety, tolerability, feasibility and efficacy of auditory SWS enhancement on measured outcomes in MCI and HD patients with disturbed nighttime sleep. Patients will be treated with verum or sham auditory stimulation for 2 consecutive nights. All interventions will take place at the patients' homes.
- Being tested
- MHSL- SleepBand, Sham
- Keywords
- sleep, neurodegeneration, slow- wave sleep
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Huntington Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHSL- SleepBandDevice
Also called Auditory SWS stimulation
The MHSL-SleepBand (sleep headband) is easy to apply and only involves attachment of sticky electrodes on different locations on the face/behind ear to be able to measure EEG (electroencephalogram), EOG (electrooculogram) and EMG (electromyogram). Brief tones at a low volume (around 60 dB, comparable to conversation) will be applied, when slow waves are present in the course of the sleep period and other criteria are fulfilled. Auditory stimulation will start with a specific volume that has been adjusted to the individual hearing capacity (usually between 45-65 dB; maximum 80 dB). The stimulation is performed in a way that the general structure of sleep (e.g. duration, sleep cycling, etc.) is unchanged.
ShamDevice
Also called Sham stimulation
Playing no tones during non- Rapid Eye Movement (NREM) sleep but wearing the device and recording the biosignals over a period of 3 nights, every night.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Patients will receive all-night auditory stimulation during sleep over 3 nights using a portable, safe, in-home device (MSHL-SleepBand). This device records biosignals (EEG) and precisely plays tones (between 45-65 dB, maximum 80 dB) targetted to the up-phase of sleep slow waves. Receives: Device: MHSL- SleepBand |
| Sham | Sham comparator | Patients will receive all-night sham stimulation over 3 nights, i.e. the wearable stimulation device will be applied (EEG will be recorded), but no tones will be played. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep quality
Changes in subjective sleep quality measured with adapted version of Parkinson Disease Sleep Scale (PDSS2), questions on a scale of 0-4, with 0 indicating better sleep
Measured: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Pilot study: feasibility of acoustic SWS enhancement
Feasibility of acoustic SWS enhancement in MCI and HD patients (enhancement of slow-waves measured with EEG)
Measured: assessed after intervention (day 10)
Secondary outcomes (11)
Vigilance
Changes in vigilance measured using Psychomotor Vigilance Test (PVT)
Measured: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Sleep benefit on motor performance
Changes in motor performance assessed with focus motor assessment
Measured: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Momentary sleepiness
Changes in momentary sleepiness assessed with Karolinska Sleepiness Scale (KSS) on a scale 1-10, with 1 indicating extreme alertness and 10 indicating extreme sleepiness
Measured: assessed before and after each intervention, and every morning and evening during the intervention (day 1 until 4, day 7 until 10)
Average sleepiness
Average sleepiness throughout the day measured with VAS on a scale 0-100, with 100 indicating extreme sleepiness
Measured: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Mood
Changes in mood assessed with Visual Analog Scale (VAS) on a scale 0-100, with 100 indicating extremely good mood
Measured: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Restorative effect of sleep
Changes in restorative effect of sleep using VAS, on a scale 0-100, with 100 indicating very refreshing sleep
Measured: assessed every morning during the intervention (day 1 until 4, day 7 until 10)
Slow wave enhancement
Enhancement of slow waves with auditory stimulation, measured with EEG
Measured: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Auditory stimulation algorithm performance
Performance of algorithm detecting and stimulating slow waves, measured with EEG
Measured: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Pilot study: changes in mood
changes in mood assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extremely good mood
Measured: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleep quality
changes in sleep quality assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extremely good sleep quality
Measured: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleepiness
changes in sleepiness assessed on VAS (Visual Analog Scale) on a scale 0-100, with 100 indicating extreme sleepiness
Measured: before and after intervention (day 1 and 4, day 7 and 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Oct 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (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 Parkinson DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized, double-blind, sham-controlled cross-over trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589182
- Sponsor's protocol ID
- PDSL-EDS
- Status last verified
- Jun 2021
- First submitted
- 29 Sep 2020
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schreiner SJ, Horlacher J, Fattinger S, Markert B, Renerts K, Brogli L, Kampf L, Scandella M, Poryazova R, Valko PO, Ferster L, Sassenburg R, Jaramillo V, Da Poian G, Lustenberger C, Karlen W, Huber R, Baumann CR, Maric A. Enhancing sleep slow waves with auditory stimulation in people with Parkinson's disease: a randomized proof-of-concept trial. Sci Rep. 2026 May 26;16(1):23984. doi: 10.1038/s41598-026-53443-1.
PubMed 42191834
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Symptomatic Benefit of Acoustic Slow Wave Enhancement in Parkinson Disease: A Randomized, Double-Blind and Placebo-Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT04589182
- Acronym / sponsor ID
- PDSL-EDS
- Keywords
- sleep, neurodegeneration, slow- wave sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 19 Oct 2020 (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 is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in Parkinson disease (PD) patients with disturbed nighttime sleep.
Additionally, the investigators will assess the feasibility and efficacy of auditory slow-wave sleep (SWS) enhancement in Mild Cognitive Impairment (MCI) and Huntington Disease (HD) patients in a pilot study.
Detailed description
The study is a randomized, double-blind, sham-controlled cross-over trial to assess the efficacy as well as safety and tolerability of auditory SWS enhancement on measured outcomes in PD patients with disturbed nighttime sleep. Patients will be randomized to 2 groups: Group 1 will first be treated with auditory stimulation for 3 nights and then - after a wash-out period of 4 nights - switched to 3 nights of sham stimulation. Group 2 will first receive sham-stimulation for 3 nights and then switch to 3 nights of auditory stimulation treatment. The wash-out period in between will be 4 nights. Patients and investigators assessing the outcomes will be blinded to the conditions. All interventions will take place at the patients' homes.
The pilot study is aimed at assessment of safety, tolerability, feasibility and efficacy of auditory SWS enhancement on measured outcomes in MCI and HD patients with disturbed nighttime sleep. Patients will be treated with verum or sham auditory stimulation for 2 consecutive nights. All interventions will take place at the patients' homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, sham-controlled cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Device: MHSL- SleepBandPatients will receive all-night auditory stimulation during sleep over 3 nights using a portable, safe, in-home device (MSHL-SleepBand). This device records biosignals (EEG) and precisely plays tones (between 45-65 dB, maximum 80 dB) targetted to the up-phase of sleep slow waves. |
| Sham | Sham comparator | Device: ShamPatients will receive all-night sham stimulation over 3 nights, i.e. the wearable stimulation device will be applied (EEG will be recorded), but no tones will be played. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Informed consent as documented by signature
- Diagnosis of PD along international criteria with mild to moderate disease severity (Hoehn- Yahr (HY) stages ll-lll),
- Self-reported sleep problems and subjectively impaired sleep quality (PDSS-2 sleep quality subscale (items 1-3 and 14) ≥7)
- Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
- Ability to apply the intervention for the duration of study, either alone or with help of co-habitant
Key exclusion criteria (41 listed)
- Known presence of neurologic (other than PD), psychiatric, or sleep disorders (others than associated with PD)
- Parkinsonism without response to levodopa; Atypical Parkinsonian syndromes
- Severe medical conditions as renal insufficiency, liver failure or congestive heart failure
- The regular use of benzodiazepines and other central nervous system (CNS)-depressant substances, as well as melatonin and other sleep inducing substances
- Inability to hear the tones produced by the MHSL-SleepBand device
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 |
|---|---|---|
| MHSL- SleepBandAlso: Auditory SWS stimulationThe MHSL-SleepBand (sleep headband) is easy to apply and only involves attachment of sticky electrodes on different locations on the face/behind ear to be able to measure EEG (electroencephalogram), EOG (electrooculogram) and EMG (electromyogram). Brief tones at a low volume (around 60 dB, comparable to conversation) will be applied, when slow waves are present in the course of the sleep period and other criteria are fulfilled. Auditory stimulation will start with a specific volume that has been adjusted to the individual hearing capacity (usually between 45-65 dB; maximum 80 dB). The stimulation is performed in a way that the general structure of sleep (e.g. duration, sleep cycling, etc.) is unchanged. | Device | Verum |
| ShamAlso: Sham stimulationPlaying no tones during non- Rapid Eye Movement (NREM) sleep but wearing the device and recording the biosignals over a period of 3 nights, every night. | Device | Sham |
Primary outcome
Subjective sleep quality
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Changes in subjective sleep quality measured with adapted version of Parkinson Disease Sleep Scale (PDSS2), questions on a scale of 0-4, with 0 indicating better sleep
Pilot study: feasibility of acoustic SWS enhancement
Time frame: assessed after intervention (day 10)
Feasibility of acoustic SWS enhancement in MCI and HD patients (enhancement of slow-waves measured with EEG)
11 secondary outcomes
Vigilance
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Sleep benefit on motor performance
Time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)
Momentary sleepiness
Time frame: assessed before and after each intervention, and every morning and evening during the intervention (day 1 until 4, day 7 until 10)
Average sleepiness
Time frame: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Mood
Time frame: assessed every evening during the intervention (day 1 until 4, day 7 until 10)
Restorative effect of sleep
Time frame: assessed every morning during the intervention (day 1 until 4, day 7 until 10)
Slow wave enhancement
Time frame: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Auditory stimulation algorithm performance
Time frame: assessed every night of the intervention (day 1 until 4, day 7 until 10)
Pilot study: changes in mood
Time frame: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleep quality
Time frame: before and after intervention (day 1 and 4, day 7 and 10)
Pilot study: changes in sleepiness
Time frame: before and after intervention (day 1 and 4, day 7 and 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Derived from this study: PubMed 42191834Schreiner SJ, Horlacher J, Fattinger S, Markert B, Renerts K, Brogli L, Kampf L, Scandella M, Poryazova R, Valko PO, Ferster L, Sassenburg R, Jaramillo V, Da Poian G, Lustenberger C, Karlen W, Huber R, Baumann CR, Maric A. Enhancing sleep slow waves with auditory stimulation in people with Parkinson's disease: a randomized proof-of-concept trial. Sci Rep. 2026 May 26;16(1):23984. doi: 10.1038/s41598-026-53443-1.
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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 MHSL- SleepBand in people with Parkinson Disease and Mild Cognitive Impairment, run by Christian Baumann 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 17 inclusion and 41 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 6 Jul 2021. 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 Simon Schreiner, MD (+41 44 355 55 11, simon.schreiner@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep quality (time frame: assessed before and after each intervention (day 1 and 4, day 7 and 10)). 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?
On the ClinicalTrials.gov record for NCT04589182, 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 6 Jul 2021.