Trials / Completed
CompletedNCT06816875
Comparison of the User Experience of Four Nasal Aspirators in Infants
Comparative Analysis of Commercially Available Nasal Aspirators in Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Children's Hospital of Eastern Ontario · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
The goal of this clinical trial is to compare the caregiver's user experience, and overall impacts on an infant's cold symptoms between four nasal aspirator devices. These devices are normally used to relieve congestion in infants. when they are sick by softening and suctioning mucus from the nose. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | 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. |
| DEVICE | 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. |
| 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. |
Timeline
- Start date
- 2025-03-05
- Primary completion
- 2025-12-17
- Completion
- 2025-12-17
- First posted
- 2025-02-10
- Last updated
- 2026-04-02
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06816875. Inclusion in this directory is not an endorsement.