Parkinson's DiseaseSynch FitNCT04467632
Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease
A study testing Validation of the mobility assessment by IMU wearable sensors and Testing in real-life conditions at patients' home in a small group of subjects in people with Parkinson's Disease, run by University Hospital Center of Martinique at 1 site in France.
Trial summary
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Validation of the mobility assessment by IMU wearable sensors and Testing in real-life conditions at patients' home in a small group of subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2019to Apr 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
- Patients > 18 years old;
- Patients affected with idiopathic PD, of both sexes;
- Hoehn and Yahr stage of 2 to 4 in the "on" state;
- Stable antiparkinsonian and/or psychotropic medications for at least 4 weeks prior to study screening;
- Reliable partner/caregiver to assist the patient during the study procedures;
- Affiliated person or beneficiary of a social security scheme;
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Patients < 18 years old;
- Atypical parkinsonian syndromes;
- Dementia;
- Treatment with extended-release dopaminergic drugs (excluding extended release levodopa given no later than 6 hours before the habitual bedtime);
- Use of hypno-sedative drugs or stimulants;
- Use of antidepressants unless on a stable dose for at least 3 months;
Show all 15Show fewer
- Travel through 2 time zones within 90 days prior to study screening;
- Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness;
- Any other medical condition potentially interfering with the assessment of mobility (e.g. limb amputation, post-stroke paralysis, severe osteo-articular condition);
- Any condition limiting the capability of the subject to understand the task to be performed at home by the patient himself (e.g. aphasia, oligophrenia);
- Severely altered physical and/or psychological health which, according to, the investigator, could affect the participant's compliance of the study;
- Inadequate housing conditions to perform home assessments;
- Patients refusing to participate in the study;
- Patients under legal guardianship or curatorship, pregnant and breastfeeding women, women of child-bearing age, persons in emergency situations;
- Persons participating in another research including a period of exclusion still in course and at any case < 1 month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs.
The SB could represent a pathway for the development of new therapeutic strategies for motor symptoms in PD.
Read more
Being a seemingly unpredictable phenomenon and a great variability daily, inter- and intra-subject, the SB study requires multiple and repeated assessments of mobility for several days. An experimental home setting would be optimal for this purpose in terms of cost-effectiveness and patient acceptability.
In addition, since the extent and nature of SB have not been well characterized so far, and the magnitude of its variability is unknown, a reliable assessment method, independent of observers and situation, the SB is a requirement of further research in this area.
A recently developed technique combining machine learning algorithms with wireless portable sensors (accelerometers and gyroscopes) and software applications could be particularly promising for characterizing the complexity and multiplicity of SBs in. With this technique, repeated and multiple assessments of mobility can be performed in the homes of patients without the constant presence of a researcher.
This approach offers several advantages in terms of cost-effectiveness, feasibility and acceptability of study protocols by patients. It also improves the ecological validity of subjective and objective estimates of mobility in these patients.
The investigators chose to conduct this preliminary study on patients with PD rather than on healthy subjects, because SB is a phenomenon that has been described so far only in this population. Investigators also consider that the feasibility of the study will depend mainly on the patients' ability to move and the context of their own illness.
SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the coordinated interaction of the duration of the previous awakening (homeostatic process) and a circadian signal (circadian process). In order to better understand SB, it is necessary to study the reciprocal influences of the circadian and homeostatic process.
Investigators have devised a new paradigm to "shift" the circadian process phase around the homeostatic process, maintained under constant conditions, in order to observe the effect of the synchronism or desynchronization of these two processes on the awakening mobility of patients with an MP. This experimental approach was approved by Professor Aleksandar Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian rhythmicity in the MP and scientific collaborator of this study.
As a first step, the investigators plan to implement a technology-assisted home-based methodology, to validate it in PD patients and to verify the logistic feasibility of this method-assisted approach in a small group of patients, in order to to be able to apply this paradigm in larger scientific projects.
Read the detailed description
Parkinson's disease is a common neurodegenerative disorder touching 1.5% of the general population over 60 year-old and featuring impaired mobility with high impact on daily living and quality of life of the patients and their caregivers. Fourty percent of the patients with Parkinson's disease (PD) report inconstant, prominent, spontaneous, transitory improvement in mobility occurring on morning awakening, before taking their first morning dose of dopaminergic medications. This apparently unpredictable, highly variable, sleep-related phenomenon has been named "Sleep Benefit" (SB) by the scientists.
SB is a promising track to follow to develop novel therapeutic strategies for motor symptoms in PD. An innovative approach could be to induce modifications of mobility by influencing sleep regulation in PD patients in experimental settings.
Sleep propensity and timing depend on the coordinated interaction of the duration of preceding wakefulness (homeostatic component) and on a circadian signal (circadian component). Reciprocal interactions between homeostatic and circadian processes preside to internal synchrony of many physiological processes. We hypothesize SB to depend on serendipitous optimal synchronization between circadian and homeostatic process on morning awakening. As SB shows high day-to-day, inter- and intra-subject variability, studying SB requires multiple, repeated assessment of mobility during several days. A home-based experimental setting would be optimal for this purpose in terms of cost-effectiveness and acceptability by the patients. Moreover, considering that the range and nature of SB has not been well characterized so far, and that the amplitude of its variability is unknown, a reliable, observer- and situation-independent, reproducible assessment method of SB is a pivotal requirement for further research in this area.
A recently developed technique associating machine-learning algorithms with wireless wearable sensors (accelerometers and gyroscopes) and software applications might be particularly promising to characterize the complexity and multiplicity of SB in PD. Thanks to this technique, repeated, multiple assessments of mobility can be performed at patients' home without the constant presence of an investigator.
The working hypothesis of this study is that motor performance in PD patients improves on morning awakening when optimal synchrony between circadian and homeostatic regulation of sleep occurs. As first step, we envision to set up a home-based and technology-assisted methodology and to verify its scientific, technological and logistic feasibility.
The study will involve four work packages, for each of which specific endpoints are defined:
WP1: Definition of the logistics, setting, practices of the study procedures for home assessment;
WP2: Technological setup of:
- IMU wearable sensors
- SleepFit software application development
- light therapy (included sham light therapy)
- home polysomnography
- chronobiological assessments (distal-proximal skin body temperature gradient; Dim Light Melatonin Onset (DLMO) from salivary specimens;
Two work packages (3 and 4) will require patients inclusion and interventions on patients:
WP3: Validation of mobility assessment by wearable sensors: accuracy of machine learning algorithm to predict patients' motor status based on the MDS-UPDRS-III total score and on the 3.14 item (global clinical impression of mobility);
WP4: Testing in real-life conditions at patients' home in a small group of subjects.
- Conditions
- Parkinson's Disease
- Being tested
- Validation of the mobility assessment by IMU wearable sensors, Testing in real-life conditions at patients' home in a small group of subjects
- Keywords
- Parkinson's Disease, Sleep benefit, circadian process, homeostatic process, circadian and homeostatic synchronization
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the mobility assessment by IMU wearable sensorsOther
The validity of the mobility assessment by IMU wearable sensors will be verified in Work Package 3.
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 MDS-UPDRS-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. A subset of minimal motor tasks allowing good prediction of the patient's motor status by the machine learning algorithm will then be selected for Work Package 4.
Testing in real-life conditions at patients' home in a small group of subjectsOther
Baseline Phase B1: Observation phase: 1-week wrist actigraphy and sleep diary to assess habitual activity/rest routines.
B2: Nocturnal sleep consolidation phase: 2 weeks: timed light exposure, constant sleep/wake routine and sleep restriction of 1 hour/night (based on habitual activity).
Testing in real-life conditions at patients' home in a small group of subjectsOther
Intervention phase
- Phase A (11 days): subjects will receive one hour of morning and afternoon light exposure twice a day:
- Day #1: baseline assessment of outcome measures;
- Days #2 to #6: bright light in the morning (active treatment) + dim light in the afternoon (placebo), to progressively advance circadian phase of 30' per day (phase advance of 2.5 hours obtained at day 6);
- Days #7 to #11: dim light in the morning + bright light in the afternoon to revert the circadian phase to the baseline of 30' per day.
- Washout: 6 days. No intervention during this phase, to stabilise the reverted circadian rhythm to baseline, for phase B to be held at the same conditions as phase A.
- Phase B (11 days): similar as in phase A:
- Day #1: similar as in phase A;
- Days #2 to #6: reverted conditions compared to phase A.
- Days #7 to #11: reverted conditions compared to phase A.
| Study group | Role | What they receive |
|---|---|---|
| Patients affected with idiopathic Parkinson Disease | Experimental | Not described Receives: Other: Validation of the mobility assessment by IMU wearable sensors; Other: Testing in real-life conditions at patients' home in a small group of subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the objective metrics of mobility
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.
Measured: 12 months
Objective and subjective mobility
Prediction of mobility by machine learning based on data from IMU wearable sensors; finger tapping test; VAS motor
Measured: 12 months
Sleep and sleepiness
Measured by sleep diary, SSS
Measured: 12 months
Cognition (electronic Stroop test)
Measured: 12 months
Emotional state
Measured by Visual Analog Scale(VAS) mood/anxiety
Measured: 12 months
Fatigue
Measured by VAS fatigue
Measured: 12 months
Circadian phase
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
Measured: 12 months
Sleep homeostasis (SWA)
Calculated based on the EEG recording acquired by means of nocturnal portable polysomnography.
Measured: 12 months
Secondary outcomes (8)
Chronotype
Measured by Horne \& Ostberg Morningness/Eveningness Questionnaire (MEQ)
Measured: 12 months
Sleep habits, sleep and wake-related symptoms, sleep quality
Measured by Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 months
PD-specific sleep and wake-associated symptoms
Measured by Parkinson's Disease Sleep Scale (PDSS-2)
Measured: 12 months
Daytime symptoms of bad or insufficient sleep
Measured by Epworth Sleepiness Scale (ESS) [96] and Fatigue Severity Scale (FSS)
Measured: 12 months
Modification of mobility on morning awakening
Measured by Sleep benefit questionnaire
Measured: 12 months
Motor and non-motor symptoms of PD in daily living
Measurded by MDS-UPDRS scale (parts I, II and IV)
Measured: 12 months
Neuropsychological battery useful in idiopathic PD
Measured by Mattis dementia rating scale (MDRS)
Measured: 12 months
Mood
Measured by Beck Depression Inventory (BDI)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study startOct 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: The principal investigator left the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pietro Luca RATTI, MD, Principal investigator, CHU de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467632
- Sponsor's protocol ID
- 19_RIPH2-12
- Acronym
- Synch Fit
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian & Homeostatic Synchronization Effect on Waking Mobility in Parkinson's Disease: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04467632
- Acronym / sponsor ID
- Synch Fit / 19_RIPH2-12
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Sleep benefit, circadian process, homeostatic process, circadian and homeostatic synchronization
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The principal investigator left the hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 13 Jul 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.
Sleep benefit (SB) consists of a spontaneous, transient and inconsistent improvement of the mobility occurring on morning awakening in approximately 40% of Parkinson's disease (PD) patients, before taking the first morning dose of dopaminergic drugs.
The SB could represent a pathway for the development of new therapeutic strategies for motor symptoms in PD.
Being a seemingly unpredictable phenomenon and a great variability daily, inter- and intra-subject, the SB study requires multiple and repeated assessments of mobility for several days. An experimental home setting would be optimal for this purpose in terms of cost-effectiveness and patient acceptability.
In addition, since the extent and nature of SB have not been well characterized so far, and the magnitude of its variability is unknown, a reliable assessment method, independent of observers and situation, the SB is a requirement of further research in this area.
A recently developed technique combining machine learning algorithms with wireless portable sensors (accelerometers and gyroscopes) and software applications could be particularly promising for characterizing the complexity and multiplicity of SBs in. With this technique, repeated and multiple assessments of mobility can be performed in the homes of patients without the constant presence of a researcher.
This approach offers several advantages in terms of cost-effectiveness, feasibility and acceptability of study protocols by patients. It also improves the ecological validity of subjective and objective estimates of mobility in these patients.
The investigators chose to conduct this preliminary study on patients with PD rather than on healthy subjects, because SB is a phenomenon that has been described so far only in this population. Investigators also consider that the feasibility of the study will depend mainly on the patients' ability to move and the context of their own illness.
SB is a phenomenon induced by sleep. The propensity and timing of sleep depend on the coordinated interaction of the duration of the previous awakening (homeostatic process) and a circadian signal (circadian process). In order to better understand SB, it is necessary to study the reciprocal influences of the circadian and homeostatic process.
Investigators have devised a new paradigm to "shift" the circadian process phase around the homeostatic process, maintained under constant conditions, in order to observe the effect of the synchronism or desynchronization of these two processes on the awakening mobility of patients with an MP. This experimental approach was approved by Professor Aleksandar Videnovic (Harvard University School of Medicine, USA), opinion leader on circadian rhythmicity in the MP and scientific collaborator of this study.
As a first step, the investigators plan to implement a technology-assisted home-based methodology, to validate it in PD patients and to verify the logistic feasibility of this method-assisted approach in a small group of patients, in order to to be able to apply this paradigm in larger scientific projects.
Detailed description
Parkinson's disease is a common neurodegenerative disorder touching 1.5% of the general population over 60 year-old and featuring impaired mobility with high impact on daily living and quality of life of the patients and their caregivers. Fourty percent of the patients with Parkinson's disease (PD) report inconstant, prominent, spontaneous, transitory improvement in mobility occurring on morning awakening, before taking their first morning dose of dopaminergic medications. This apparently unpredictable, highly variable, sleep-related phenomenon has been named "Sleep Benefit" (SB) by the scientists.
SB is a promising track to follow to develop novel therapeutic strategies for motor symptoms in PD. An innovative approach could be to induce modifications of mobility by influencing sleep regulation in PD patients in experimental settings.
Sleep propensity and timing depend on the coordinated interaction of the duration of preceding wakefulness (homeostatic component) and on a circadian signal (circadian component). Reciprocal interactions between homeostatic and circadian processes preside to internal synchrony of many physiological processes. We hypothesize SB to depend on serendipitous optimal synchronization between circadian and homeostatic process on morning awakening. As SB shows high day-to-day, inter- and intra-subject variability, studying SB requires multiple, repeated assessment of mobility during several days. A home-based experimental setting would be optimal for this purpose in terms of cost-effectiveness and acceptability by the patients. Moreover, considering that the range and nature of SB has not been well characterized so far, and that the amplitude of its variability is unknown, a reliable, observer- and situation-independent, reproducible assessment method of SB is a pivotal requirement for further research in this area.
A recently developed technique associating machine-learning algorithms with wireless wearable sensors (accelerometers and gyroscopes) and software applications might be particularly promising to characterize the complexity and multiplicity of SB in PD. Thanks to this technique, repeated, multiple assessments of mobility can be performed at patients' home without the constant presence of an investigator.
The working hypothesis of this study is that motor performance in PD patients improves on morning awakening when optimal synchrony between circadian and homeostatic regulation of sleep occurs. As first step, we envision to set up a home-based and technology-assisted methodology and to verify its scientific, technological and logistic feasibility.
The study will involve four work packages, for each of which specific endpoints are defined:
WP1: Definition of the logistics, setting, practices of the study procedures for home assessment;
WP2: Technological setup of:
- IMU wearable sensors
- SleepFit software application development
- light therapy (included sham light therapy)
- home polysomnography
- chronobiological assessments (distal-proximal skin body temperature gradient; Dim Light Melatonin Onset (DLMO) from salivary specimens;
Two work packages (3 and 4) will require patients inclusion and interventions on patients:
WP3: Validation of mobility assessment by wearable sensors: accuracy of machine learning algorithm to predict patients' motor status based on the MDS-UPDRS-III total score and on the 3.14 item (global clinical impression of mobility);
WP4: Testing in real-life conditions at patients' home in a small group of subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected with idiopathic Parkinson Disease | Experimental | Other: Validation of the mobility assessment by IMU wearable sensors, Other: Testing in real-life conditions at patients' home in a small group of subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients > 18 years old;
- Patients affected with idiopathic PD, of both sexes;
- Hoehn and Yahr stage of 2 to 4 in the "on" state;
- Stable antiparkinsonian and/or psychotropic medications for at least 4 weeks prior to study screening;
- Reliable partner/caregiver to assist the patient during the study procedures;
Key exclusion criteria (15 listed)
- Patients < 18 years old;
- Atypical parkinsonian syndromes;
- Dementia;
- Treatment with extended-release dopaminergic drugs (excluding extended release levodopa given no later than 6 hours before the habitual bedtime);
- Use of hypno-sedative drugs or stimulants;
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 |
|---|---|---|
| Validation of the mobility assessment by IMU wearable sensorsThe validity of the mobility assessment by IMU wearable sensors will be verified in Work Package 3. 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 MDS-UPDRS-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. A subset of minimal motor tasks allowing good prediction of the patient's motor status by the machine learning algorithm will then be selected for Work Package 4. | Other | Patients affected with idiopathic Parkinson Disease |
| Testing in real-life conditions at patients' home in a small group of subjectsBaseline Phase B1: Observation phase: 1-week wrist actigraphy and sleep diary to assess habitual activity/rest routines. B2: Nocturnal sleep consolidation phase: 2 weeks: timed light exposure, constant sleep/wake routine and sleep restriction of 1 hour/night (based on habitual activity). | Other | Patients affected with idiopathic Parkinson Disease |
| Testing in real-life conditions at patients' home in a small group of subjectsIntervention phase * Phase A (11 days): subjects will receive one hour of morning and afternoon light exposure twice a day: * Day #1: baseline assessment of outcome measures; * Days #2 to #6: bright light in the morning (active treatment) + dim light in the afternoon (placebo), to progressively advance circadian phase of 30' per day (phase advance of 2.5 hours obtained at day 6); * Days #7 to #11: dim light in the morning + bright light in the afternoon to revert the circadian phase to the baseline of 30' per day. * Washout: 6 days. No intervention during this phase, to stabilise the reverted circadian rhythm to baseline, for phase B to be held at the same conditions as phase A. * Phase B (11 days): similar as in phase A: * Day #1: similar as in phase A; * Days #2 to #6: reverted conditions compared to phase A. * Days #7 to #11: reverted conditions compared to phase A. | Other | Patients affected with idiopathic Parkinson Disease |
Primary outcome
Validation of the objective metrics of mobility
Time frame: 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.
Objective and subjective mobility
Time frame: 12 months
Prediction of mobility by machine learning based on data from IMU wearable sensors; finger tapping test; VAS motor
Sleep and sleepiness
Time frame: 12 months
Measured by sleep diary, SSS
Cognition (electronic Stroop test)
Time frame: 12 months
Emotional state
Time frame: 12 months
Measured by Visual Analog Scale(VAS) mood/anxiety
Fatigue
Time frame: 12 months
Measured by VAS fatigue
Circadian phase
Time frame: 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
Sleep homeostasis (SWA)
Time frame: 12 months
Calculated based on the EEG recording acquired by means of nocturnal portable polysomnography.
8 secondary outcomes
Chronotype
Time frame: 12 months
Sleep habits, sleep and wake-related symptoms, sleep quality
Time frame: 12 months
PD-specific sleep and wake-associated symptoms
Time frame: 12 months
Daytime symptoms of bad or insufficient sleep
Time frame: 12 months
Modification of mobility on morning awakening
Time frame: 12 months
Motor and non-motor symptoms of PD in daily living
Time frame: 12 months
Neuropsychological battery useful in idiopathic PD
Time frame: 12 months
Mood
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Pietro Luca RATTI, MD principal investigator
CHU de Martinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validation of the mobility assessment by IMU wearable sensors and Testing in real-life conditions at patients' home in a small group of subjects in people with Parkinson's Disease, run by University Hospital Center of Martinique at 1 site in France.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 13 Jul 2020. 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 France. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the objective metrics of mobility (time frame: 12 months). The study lists 8 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 13 Jul 2020.