Healthy Clinical Trial
— COOLOfficial title:
Cry Management and Awareness Tool (Cool): A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Verified date | June 2020 |
Source | Danone Asia Pacific Holdings Pte, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Primary: The rating by the primary caregivers on the use and relevance of data provided by
the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the
content on the Cool mobile app.
Secondary: The rating by the Healthcare Professionals (HCPs) on the use and relevance of data
provided by the LENA recorder in their general practice
Exploratory
- Total crying and fussing time captured by the LENA recorder
- Crying and fussing time perceived by the parents
- Vital parameters like heart rate, sleep recorded by the Fitbit used by the primary
caregiver during crying and fussing events registered by LENA
- Comments and feedback provided by the primary caregiver on the LENA recorder and the
Cool mobile app
- Comments and feedback provided by the HCP on the LENA recorder and the data provided.
- Sleep time recorded by the Cocoon Cam
- Crying time recorded by the Cocoon Cam
- Crying start and end time recorded by the primary caregiver in the COOL app
- Sleep start and end time recorded by the primary caregiver in the COOL app
- Comments and feedback provided by the primary caregiver and HCP on the Cocoon Cam and
the activity log for infant cry and sleep including push notifications in the Cocoon Cam
app
- Usage data from the Cocoon Cam app
Status | Completed |
Enrollment | 20 |
Est. completion date | September 17, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 12 Months |
Eligibility |
Inclusion Criteria: 1. Infants aged 2 to 12 months. 2. Primary caregiver should have reliable access to the internet and a reliable device such as a computer, tablet or smart phone to access the Cool mobile app and able to view the LENA data and complete questionnaires. 3. Primary caregiver should be adequately skilled comfortable in English to read the content in the Cool mobile app and complete questionnaires. 4. Primary caregiver takes care of the child more than 50% of the time. Exclusion Criteria: 1. Primary caregiver who is not adequately skilled comfortable in English language to read the content in the Cool mobile app and complete questionnaires. 2. Incapability of the primary caregiver to access Cool mobile app through internet. |
Country | Name | City | State |
---|---|---|---|
Singapore | SBCC Clinic Pte Ltd | Singapore |
Lead Sponsor | Collaborator |
---|---|
Danone Asia Pacific Holdings Pte, Ltd. | Techobserver |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder | Exploratory Parameter : Total daily crying and fussing time captured by the LENA recorder in minutes | 2 weeks | |
Other | Exploratory Parameter :Crying and Fussing Time Perceived by the Parents | Daily duration of cry and/or fuss in the scale of : <30 mins 30 mins to 1hr >1hr to 3hrs > 3hrs |
2 weeks | |
Other | Usage Time of the Cocoon Cam App by the Primary Caregiver | Usage time (in minutes) of the Cocoon Cam app by the primary caregiver. | 2 weeks | |
Other | To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice | To explore the usability of Cocoon Cam and data captured by the Cocoon Cam app for the HCP in their daily practice. Scale 0 = Not at all, Scale 5 = Yes very much. Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks | |
Primary | The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App. | Rating by the primary caregiver about the usability and relevance using a 6-point scale [0=Not at all, 5=Yes, very much]; Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks | |
Secondary | The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. | Rating by the HCP about the use and relevance of the LENA data in general practice using 6 point scale [0=Not at all, 5=Yes, very much], Scale 1 to 4 is subjective to user definition (not defined specifically) | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |