Comparison of the User Experience of Four Nasal Aspirators in Infants
NCT ID: NCT06816875
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
28 participants
INTERVENTIONAL
2025-03-05
2025-07-31
Brief Summary
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The main questions it aims to answer are:
What is the caregiver's user experience of the NozeBot electric nasal aspirator compared to three commonly accessible nasal aspirator devices?
Are there changes in the infant's sleeping, feeding, or breathing as reported by the caregiver when using the NozeBot compared to the three other nasal aspirator devices?
Are there changes in their caregiver's habits when using the NozeBot compared to the three other nasal aspirator devices?
Researchers will compare the self-reported measures of caregiver's user experience, reported changes to their infant's symptoms, and reported changes to their own sleeping and care habits between the NozeBot electric nasal aspirator and three comparator devices: the NoseFrida SnotSucker, the hydraSense Baby Nasal Aspirator Kit, and the Braun electric nasal aspirator.
Participants will be assigned to receive one of the four devices at the start of their participation. They will be asked to use the assigned device at home according to the device instructions during two periods: (1) for 10 days while their infant is sick, and (2) for up to 3 months after.
During these periods, participants will be asked to complete online surveys at predetermined intervals to report the user experience, any changes to their infant's sleeping, feeding or breathing, and any changes to their own sleeping habits and perceived stress levels. These intervals for survey completion are: (i) after 1-2 days of use while their infant is sick, (ii) after 4-5 days of use while their infant is sick, (iii) after 7-10 days of use while their infant is sick, and then (iv) biweekly for 3 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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NozeBot Arm
Participants assigned to this group will receive the NozeBot electric nasal aspirator device.
NozeBot Electric Nasal Aspirator
The NozeBot is a rechargeable, battery-operated baby nasal aspirator with a nosepiece that loops directly onto the caregivers fingers for ease of use, and is intended to be held so it sits just inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
NoseFrida Arm
Participants assigned to this group will receive NoseFrida the SnotSucker product.
NoseFrida the SnotSucker
The NoseFrida is nose-to-mouth nasal suctioning device with a disposable hygienic filter. The nosepiece is a larger tube that is to be held so it sits against and not inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
hydraSense Arm
Participants assigned to this group will receive the hydraSense Baby Nasal Aspirator Starter Kit.
hydraSense Baby Nasal Care Nasal Aspirator Starter Kit
The hydraSense Baby Nasal Aspirator Starter Kit is a nose-to-mouth nasal suctioning device with a disposable hygienic filter. The kit contains pre-proportioned saline solution vials to liquify mucus prior to suctioning. The nosepiece is intended to be held so it sits inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
Braun Arm
Participants assigned to this group will receive the Braun nasal aspirator device.
Braun Nasal Aspirator
The Braun nasal aspirator is a battery-operated nasal suctioning device with a washable collection chamber for mucus. There are two nosepiece sizes to accommodate a best fit in the nose. It will be used according to its manufacturer's instructions for use in this study.
Interventions
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NozeBot Electric Nasal Aspirator
The NozeBot is a rechargeable, battery-operated baby nasal aspirator with a nosepiece that loops directly onto the caregivers fingers for ease of use, and is intended to be held so it sits just inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
NoseFrida the SnotSucker
The NoseFrida is nose-to-mouth nasal suctioning device with a disposable hygienic filter. The nosepiece is a larger tube that is to be held so it sits against and not inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
hydraSense Baby Nasal Care Nasal Aspirator Starter Kit
The hydraSense Baby Nasal Aspirator Starter Kit is a nose-to-mouth nasal suctioning device with a disposable hygienic filter. The kit contains pre-proportioned saline solution vials to liquify mucus prior to suctioning. The nosepiece is intended to be held so it sits inside the nose to create a seal. It will be used according to its manufacturer's instructions for use in this study.
Braun Nasal Aspirator
The Braun nasal aspirator is a battery-operated nasal suctioning device with a washable collection chamber for mucus. There are two nosepiece sizes to accommodate a best fit in the nose. It will be used according to its manufacturer's instructions for use in this study.
Eligibility Criteria
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Inclusion Criteria
* They have a child between 2 months - 18 months of age
* They are seeking outpatient care for that child for a respiratory illness (cold, flu, RSV) at the Kids Come First Care clinic
* The child does not have any contraindications to the use of a nasal aspirator
* The parent(s)/caregiver(s) are fluent in English
Exclusion Criteria
* They have a child younger than 2 months or 13 months old or older currently seeking outpatient care for a respiratory illness
* The child is admitted to hospital
* The child does not have a respiratory illness
* The child has a diagnosed craniofacial syndrome
* The child has a defined contraindication and cannot use a nasal aspirator
* The parents/caregivers are not comfortable using a nasal aspirator
* The parent/caregivers are not fluent in English
ALL
Yes
Sponsors
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Dr. Noze Best LLC
UNKNOWN
Children's Hospital of Eastern Ontario
OTHER
Responsible Party
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Valerie Cote
Physician
Locations
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Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEO REB# 25/07X
Identifier Type: -
Identifier Source: org_study_id
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