Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment
NCT04736017, Not applicable, Unknown, University of Zurich
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Auditory Slow Wave Enhancement in Parkinson Disease and Mild Cognitive Impairment | ClinicalTrials.gov |
| NCT number | NCT04736017 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Zurich | ClinicalTrials.gov |
| Conditions | Parkinson Disease, Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | TSB Axo | ClinicalTrials.gov |
| First posted | 2021-02-03 | ClinicalTrials.gov |
| Last updated | 2022-11-15 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Difference in objective EDS | 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 | ClinicalTrials.gov |
| Primary | Difference in verbal episodic memory performance | 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 | ClinicalTrials.gov |
| Secondary | Subjective EDS | 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) | ClinicalTrials.gov |
| Secondary | Sustained attention | assessed after each intervention (day 15 of each intervention) | Sustained attention, measured with the Sustained Attention to Response Task (SART) | ClinicalTrials.gov |
| Secondary | Vigilance | assessed after each intervention (day 15 of each intervention) | Vigilance, measured with the Psychomotor Vigilance Task (PVT) | ClinicalTrials.gov |
| Secondary | Subjective nocturnal sleep quality | 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 | ClinicalTrials.gov |
| Secondary | Executive Function and attention | 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 | ClinicalTrials.gov |
| Secondary | Plasma biomarkers | 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 | ClinicalTrials.gov |
| Secondary | Subjective sleep quality | 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 | ClinicalTrials.gov |
| Secondary | Subjective mood | 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 | ClinicalTrials.gov |
| Secondary | Subjective momentary sleepiness | 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) | ClinicalTrials.gov |
| Secondary | Digital biomarkers | assessed every day during the intervention (days 1-15 of each intervention) | tapping behavior on tablet | ClinicalTrials.gov |
| Secondary | Sleep intensity | 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 | ClinicalTrials.gov |
| Secondary | Depressive symptoms | 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 | ClinicalTrials.gov |
| Secondary | Verbal episodic and visuospatial memory function | 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 | ClinicalTrials.gov |
| Secondary | Quality of life (VAS) | 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 | ClinicalTrials.gov |
| Secondary | Motor symptoms | 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 | ClinicalTrials.gov |
| Secondary | Focused motor assessment | assessed on day 4 of each intervention | Assessment of hand/finger movements, in Parkinson patients | ClinicalTrials.gov |
| Secondary | Overnight memory consolidation | 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 | ClinicalTrials.gov |
| Secondary | Overnight restoration inhibitory control | 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 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 9
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Verbal Learning | Primary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Go/No-Go Task | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Sustained Attention to Response | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)