Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease
NCT04467632, Not applicable, Withdrawn, University Hospital Center of Martinique
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease | ClinicalTrials.gov |
| NCT number | NCT04467632 | ClinicalTrials.gov |
| Status | Withdrawn | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 0 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University Hospital Center of Martinique | ClinicalTrials.gov |
| Conditions | Parkinson's Disease | ClinicalTrials.gov |
| Interventions | Validation of the mobility assessment by IMU wearable sensors, Testing in real-life conditions at patients' home in a small group of subjects, Testing in real-life conditions at patients' home in a small group of subjects | ClinicalTrials.gov |
| First posted | 2020-07-13 | ClinicalTrials.gov |
| Last updated | 2020-07-13 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Validation of the objective metrics of mobility | 12 months | The validity of the mobility assessment by Inertial Measurement Unit (IMU) wearable sensors will be verified. It will be defined as the accuracy of the machine learning algorithm to predict patients' motor status compared to the motor status assessed at clinical examination by means of the MDSUPDRS- III scale and the Fit test. Prediction by machine learning will be compared with the MDS-UPDRS-III total score and with the 3.14 item (global clinical impression of mobility) of the same scale. The patients will be asked to perform all the motor tasks of the MDS-UPDRS-III scale and the finger tapping test (Fit test) with both hands wearing the IMU system. | ClinicalTrials.gov |
| Primary | Objective and subjective mobility | 12 months | Prediction of mobility by machine learning based on data from IMU wearable sensors; finger tapping test; VAS motor | ClinicalTrials.gov |
| Primary | Sleep and sleepiness | 12 months | Measured by sleep diary, SSS | ClinicalTrials.gov |
| Primary | Cognition (electronic Stroop test) | 12 months | ClinicalTrials.gov | |
| Primary | Emotional state | 12 months | Measured by Visual Analog Scale(VAS) mood/anxiety | ClinicalTrials.gov |
| Primary | Fatigue | 12 months | Measured by VAS fatigue | ClinicalTrials.gov |
| Primary | Circadian phase | 12 months | Continuously for skin body temperature and repeated samples (every 30' for a total of 9 samples, in the evening around the bed time, for salivary DLMO | ClinicalTrials.gov |
| Primary | Sleep homeostasis (SWA) | 12 months | Calculated based on the EEG recording acquired by means of nocturnal portable polysomnography. | ClinicalTrials.gov |
| Secondary | Chronotype | 12 months | Measured by Horne \& Ostberg Morningness/Eveningness Questionnaire (MEQ) | ClinicalTrials.gov |
| Secondary | Sleep habits, sleep and wake-related symptoms, sleep quality | 12 months | Measured by Pittsburgh Sleep Quality Index (PSQI) | ClinicalTrials.gov |
| Secondary | PD-specific sleep and wake-associated symptoms | 12 months | Measured by Parkinson's Disease Sleep Scale (PDSS-2) | ClinicalTrials.gov |
| Secondary | Daytime symptoms of bad or insufficient sleep | 12 months | Measured by Epworth Sleepiness Scale (ESS) \[96\] and Fatigue Severity Scale (FSS) | ClinicalTrials.gov |
| Secondary | Modification of mobility on morning awakening | 12 months | Measured by Sleep benefit questionnaire | ClinicalTrials.gov |
| Secondary | Motor and non-motor symptoms of PD in daily living | 12 months | Measurded by MDS-UPDRS scale (parts I, II and IV) | ClinicalTrials.gov |
| Secondary | Neuropsychological battery useful in idiopathic PD | 12 months | Measured by Mattis dementia rating scale (MDRS) | ClinicalTrials.gov |
| Secondary | Mood | 12 months | Measured by Beck Depression Inventory (BDI) | 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 2
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 |
|---|---|---|
| Finger Tapping Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary 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)