Comparison of the User Experience of Four Nasal Aspirators in Infants

NCT ID: NCT06816875

Last Updated: 2025-04-02

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NozeBot Arm

Participants assigned to this group will receive the NozeBot electric nasal aspirator device.

Group Type EXPERIMENTAL

NozeBot Electric Nasal Aspirator

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

NoseFrida the SnotSucker

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

hydraSense Baby Nasal Care Nasal Aspirator Starter Kit

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Braun Nasal Aspirator

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr. Noze Best LLC

UNKNOWN

Sponsor Role collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Responsible Party

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Valerie Cote

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Valerie Cote

Role: CONTACT

613-797-7600 ext. 3657

Facility Contacts

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Valerie Cote

Role: primary

613-797-7600 ext. 3657

Other Identifiers

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CHEO REB# 25/07X

Identifier Type: -

Identifier Source: org_study_id

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