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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01925-42 | Other Identifier | ANSM |
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The study aims to constitute a longitudinal Syde® digital health technology (DHT) dataset to serve as a healthy adult reference for Syde® digital variables development and validation. Subjects will be assessed every 6 months for 2 years.
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| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal change of SV95C (stride velocity 95th centile) | Change of SV95C between baseline and Month 6, Month 12, Month 18 and Month 24. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the transversal adherence of the Syde® device in healthy adults |
| Baseline |
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Inclusion Criteria:
Male or female aged between 18 and 65 years old
Signed informed consent
Subjects with a reported BMI ≥ 17 and ≤ 35
Subject with unlimited internet connection at home and authorizing automatic data upload
Subject willing and able to comply with all study procedures including:
Subject confirming to be affiliated to, or beneficiary from, a social security category
Exclusion Criteria:
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Subjects will be initially provided with information on the study through Ethics Committee validated advertising supports (paper and electronic posters and flyers). These supports will be displayed and distributed by the investigational sites.
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| Name | Affiliation | Role |
|---|---|---|
| Shotaro Tachibana | Hospices Civils de Lyon - Hôpital Femme Mère Enfant (HFME) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Femme Mère Enfant (HFME) | Bron | 69500 | France | |||
| Hôpital NOVO (Nord-Ouest Val d'Oise) |
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| Assess the transversal acceptability of the Syde® device in healthy adults |
Usability score at baseline |
| Baseline |
| Assess the longitudinal adherence of the Syde® device in healthy adults |
| 2 years |
| Assess the longitudinal acceptability of the Syde® device in healthy adults | Change in usability score between baseline and Month 24 | 2 years |
| Assess the reliability of Syde® in healthy adults | Reproducibility assessed by ICC (Intra-Class Correlation) and Bland and Altman analysis at each timepoint | 2 years |
| Evaluate in this healthy adult cohort the transversal effect on Syde® digital endpoints of gender | Correlation between Syde® derived endpoints and gender. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile). | Baseline |
| Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of age | Correlation between Syde® derived endpoints and age. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) . | Baseline |
| Evaluate in this healthy adult cohorts the transversal effect on Syde® digital endpoints of BMI | Correlation between Syde® derived endpoints and BMI. The Syde® derived endpoints will include the SV95C (stride velocity 95th centile) . | Baseline |
| Investigate the relationship between changes in Syde® derived endpoints and changes in age | Comparison between changes in Syde® derived endpoints and changes in age between baseline and Month 6, Month 12, Month 18 and Month 24. | Month 6, Month 12, Month 18, Month 24 |
| Investigate the relationship between changes in Syde® derived endpoints and changes in BMI | Comparison between changes in Syde® derived endpoints and changes in BMI between baseline and Month 6, Month 12, Month 18 and Month 24. | Month 6, Month 12, Month 18, Month 24 |
| Pontoise |
| 95300 |
| France |
| CHU ROUEN - Hôpital Charles Nicolle | Rouen | 76000 | France |
| SYSNAV | Vernon | 27200 | France |