Clinical trial NCT06816875: Comparison of the User Experience of Four Nasal Aspirators in Infants
Official title: Comparative Analysis of Commercially Available Nasal Aspirators in Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Respiratory Tract Infection
Keywords: nasal aspirator in infants
user experience of nasal aspirators
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Dr. Noze Best LLC
First posted: 2025-02-10
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria

A parent(s)/caregiver(s)/family will be eligible to participate if:

* 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

A parent(s)/caregiver(s)/family will be ineligible to participate if:

* 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

Primary outcomes:
measure: Differences in the caregiver's user experience on device ease of use between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at all follow ups, from the first survey completed at 1-2 days of device use to the final survey completed at the end of the third month of use per participant
measure: Differences in the caregiver's satisfaction between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at the 7-10 days of device use to the final survey completed at the end of the third month of use per participant.
measure: Differences in the caregiver's reported net promoter score between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at the 7-10 days of device use to the final survey completed at the end of the third month of use per participant.
Secondary outcomes:
measure: Self-reported changes in the caregiver's sleep habits between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at the 1-2 days of use, 4-5 days of use, and 7-10 days of use follow up surveys.
measure: Self-reported changes in the caregiver's perceived ability to care for their sick child between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at all follow ups, from the first survey completed at 1-2 days of device use to the final survey completed at the end of the third month of use per participant
measure: Self-reported changes in the caregiver's perceived stress levels while caring for a sick child between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at all follow ups, from the first survey completed at 1-2 days of device use to the final survey completed at the end of the third month of use per participant
measure: Caregiver-reported changes in their infant's sleeping habits between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at the 1-2 days of use, 4-5 days of use, and 7-10 days of use follow up surveys.
measure: Caregiver-reported changes in their infant's feeding habits between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at the 1-2 days of use, 4-5 days of use, and 7-10 days of use follow up surveys.
measure: Caregiver-reported perceived changes in their infant's breathing between the NozeBot and the NoseFrida, hydraSense and Braun devices
timeFrame: This is reported at all follow ups, from the first survey completed at 1-2 days of device use to the final survey completed at the end of the third month of use per participant
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References: