Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment (PDMCI-TS)

November 14, 2022 updated by: University of Zurich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8050
        • Recruiting
        • University Hospital Zurich, Neurology Department
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Verum
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.
Device: TSB Axo
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.
Sham Comparator: Sham
Playing no tones during NREM sleep but wearing the device and recording the biosignals over a period of 2 weeks, every night.
Device: TSB Axo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
assessed after each intervention (day 15 of each intervention)
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
assessed after each intervention (day 15 of each intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective EDS
Time Frame: assessed before and after each intervention (day 1 and 15 of each intervention)
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)
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)
Sustained attention, measured with the Sustained Attention to Response Task (SART)
assessed after each intervention (day 15 of each intervention)
Vigilance
Time Frame: assessed after each intervention (day 15 of each intervention)
Vigilance, measured with the Psychomotor Vigilance Task (PVT)
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)
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
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)
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
assessed after each intervention (day 15 of each intervention)
Plasma biomarkers
Time Frame: assessed after each intervention (day 15 of each intervention)
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
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 sleep quality measured with a Visual Analog Scale (VAS) on a scale from very poor to very good
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 mood during daytime measured with a Visual Analog Scale (VAS) on a scale from very poor to very good
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)
Subjective momentary sleepiness measured with Karolinska Sleepiness Scale (KSS; score ranges from 1 to 9, higher scores indicate greater momentary sleepiness)
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)
tapping behavior on tablet
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)
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
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)
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
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)
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
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)
Quality of life, measured with a Visual Analog Scale (VAS) on a scale from very poor to very good, in Parkinson patients
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)
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
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
Assessment of hand/finger movements, in Parkinson patients
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 memory consolidation, assessed with a word-pair task and finger tapping sequence test in PD and MCI patients
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 of inhibitory control, assessed with the Go/NoGo Task (GNG) in PD and MCI patients
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 of the working memory, assessed by the 2-back task in PD and MCI patients
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
Overnight restoration of vigilance, assessed by the Psychomotor Vigilance Test (PVT) in PD and MCI patients
assessed in the evening of day 13 and in the morning of day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angelina Maric, PhD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDMCI-TS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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