A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Condition: Healthy
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      At screening visit, after parent(s)/guardian(s) of potential subjects and/or legal
      representatives have been informed about the study, they will be requested to sign the
      informed consent form (ICF) prior to start of the study. After successful signing of the
      informed consent, the investigator will assess the eligibility of the subjects. If the
      subject meets all the inclusion and none of the exclusion criteria, the primary caregiver
      will complete a detailed questionnaire on subject's demographics, birth, family, feeding
      characteristics and primary caregiver's characteristics. The primary caregiver will be
      provided the LENA recorder kit and in case consented for Fitbit, they will be provided with
      the Fitbit. The primary caregiver will need to complete a training period in order to verify
      subject's primary caregiver's ability to properly connect, operate and upload data using the
      LENA recorders and uploader. As part of the training period, the primary caregiver will do
      1-2 hours of recording using the LENA recorder and successfully upload the data into the LENA
      cloud server through the internet. Once the study coordinator verifies that the upload is
      successful, the training and feasibility assessment will be considered as complete and the
      subject will be considered as enrolled. The primary caregiver of the enrolled subject will be
      provided access to the COOL mobile app and the recording period will start.

      During the recording period, the subject will be using the LENA recorder and will complete a
      daily questionnaire at the end of each day. At the end of 7 days, the site will perform a
      phone call and the LENA cry and fuss clock generated from the LENA recorder data for the
      recorded period will be shared with the primary caregiver through the COOL mobile app. After
      viewing the cry and fuss clock, the primary caregiver will need to complete a questionnaire
      on the use of LENA recorder and the content of the COOL mobile app. The primary caregiver
      will continue using the LENA recorder for the next 7 days. At the end of 14 days, the LENA
      cry and fuss data for the recorded period will be shared with the primary caregiver and the
      primary caregiver will need to complete another questionnaire on the use and relevance of the
      cry and fuss clock and overall relevance of the COOL mobile app. At the end of the recording
      period, the primary caregiver will schedule an appointment with the PI. If the primary
      caregiver consents for the use of Fitbit, they will be provided Fitbit to record their vital
      parameters like heartrate and sleep pattern through the 14 days after enrolment. At the end
      of study visit, the primary caregiver will discuss the data provided by the LENA recorder and
      the COOL mobile app with the PI and PI will use the data to explain to the primary care giver
      if there is any specific cry pattern that could be assessed based on the objective data from
      LENA. The Primary caregiver and PI will complete a questionnaire each on the use of the data
      provided by the LENA recorder during their discussion.

      For up to 5 subjects in the study, if the primary caregiver consents for the use of Cocoon
      Cam they will be provided with the Cocoon Cam kit at screening visit. The primary caregiver
      will need to complete a training period to verify the ability to properly connect, operate
      and upload data using the LENA recorders and uploader as well as the Cocoon Cam. As part of
      the training period, the primary caregiver will have to I) perform 1-2 hours of recording
      using the LENA recorder II) successfully upload the data into the LENA cloud server through
      the internet, III) use the Cocoon Cam for 1 day, and IV) be able to start using the Cocoon
      Cam application. Once the study coordinator verifies that the LENA upload is successful and
      Cocoon Cam set-up is complete, the training and feasibility assessment will be considered as
      complete and the subject will be considered as enrolled. The primary caregiver of the
      enrolled subject will be provided access to the COOL mobile app and the recording period will
      start. During the recording period, in addition to the daily questionnaire, the primary
      caregiver need to enter cry and sleep time using the COOL app. At the end of 7th day and 14th
      day, the primary caregiver need to complete questionnaires on the usability of the Cocoon
      Cam.
    

Intervention name(s): LENA recorder
Intervention type(s): Other
Intervention description(s): The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires
Other intervention name(s): Fitbit, Cool Mobile app,Cocoon Cam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other