None listed
Conditions
Interventions
Intervention1: Faros sensor and LifeInsight Hub, along with sufficient skin attachments: 1. Faros sensor- Data acquisition device
2. LifeInsight Hub - Wireless data transmission device
3. Chest strap
Sponsors
GlaxoSmithKline Consumer Healthcare GSKCH
Jehangir Clinical Development Centre Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Demonstrates understanding of the study and willingness to participate. 2. Good general and mental health and no clinically significant and relevant abnormalities in medical history or upon physical examination. 3. Absence of any condition that would impact on the participantâ??s safety or wellbeing 4.Participant and participantâ??s parents/LAR understand and are willing, able and likely to comply with all study procedures and restrictions. 5. Able to read and comprehend one of the languages used for study visits and assessments.
Exclusion criteria
Exclusion criteria: 1.A child cared for by foster parents or living in a care home or institution. 2.Concurrent Medication/ Medical History Use of concomitant medication that, in the opinion of the Principal Investigator, might interfere with the outcome of the study. 3.Allergy/ Intolerance Known or suspected intolerance or hypersensitivity to the study materials. 4.Participation in another clinical study within 30 days of the screening visit. 5.Previous participation in this study. 6.Recent history (within the last one year) of alcohol or other substance abuse. 7.An employee of the sponsor or the study site or members of their immediate family/ OR Sibling of child already part of this study. 8.Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Movement/physical activity during structured exercise 2. Heart Rate Variability (HRV) during structured exerciseTimepoint: 1. Up to 72 hours 2. Up to 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Movement/physical activity and heart rate variability during spontaneous daily physical activity, including sleep 2. Heart rate variability during spontaneous daily physical activity, including sleepTimepoint: 1. Up to 72 hours 2. Up to 72 hours | — |
Countries
India
Contacts
Public ContactDr S A Cruze
Krumur Sports Academy
Outcome results
None listed