Nasal CongestionNCT01129765
Home Usability of a Nasal Lavage System in Children
An observational study of Nasal Congestion and Respiratory Tract Infection, run by Aardvark Medical Company at 1 site in United States.
Trial summary
This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Nasal Congestion, Respiratory Tract Infection, Sinusitis
- What is being tested?
- Use of an automatic nasal irrigator/aspirator
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The participants were selected from a primary care pediatric clinic.
Who may be able to join
- Parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed.
Who cannot join
- Parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning.
- Additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use.
Read the detailed description
Nasal congestion is an important complication of viral upper respiratory infections in young children. It can lead to poor eating, sleeping and breathing. Recently, the FDA recommended against using over-the-counter cold remedies in young children because of inefficacy and occasional dangerous side effects. A commonly recommended non-drug solution for nasal congestion is nasal suctioning. This can be effective but currently available methods have been found to be awkward, uncomfortable and ineffective.
The studied device has potential for making nasal suctioning easy to perform in the home setting, especially in young children. It is already FDA cleared for professional use and this study was developed to demonstrate that it is appropriate for the home as well. This would be significant as it would allow parents a strategy of clearing their child's nose without drugs.
The device is automatic and handheld that can irrigate and/or aspirate the nasal cavity with hospital-grade suction. The handle houses a pump that can achieve air flows known to be effective for infant nasal suctioning in the hospital. A disposable wash-head is placed on top. It has an irrigation chamber with 0.9% saline and another chamber for collecting the aspirated nasal contents. The unit operates from a single bi-functional button.
Several key safety features have been built in such as: a tip that is shaped to maximize the seal but prevent intrusion into the nose; an irrigation function that delivers an optimal volume but prevents flooding the nasal cavity; and a pump that can deliver suction known to be effective in the hospital but whose safety valve does not allow it to rise above dangerous levels.
Participants were parents of children who have nasal congestion for whom nasal suctioning is traditionally recommended. They were asked to review the instruction manual of the device, and then use it on their children.
The primary outcome was proper use of device that was precisely defined. Additionally, subjective efficacy of mucus removal, evidence of adverse events and understanding of the device's user manual were also measured.
- Being tested
- Use of an automatic nasal irrigator/aspirator
- Keywords
- Nasal suction, Nasal aspiration, Nasal saline irrigation, Nasal lavage
- Medical subject headings
- Nasal Obstruction, Respiratory Tract Infections, Sinusitis, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an automatic nasal irrigator/aspiratorDevice
Also called Nasal aspiration, Nasal irrigation, Nasal lavage
After reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Parents of congested children | Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended. Receives: Device: Use of an automatic nasal irrigator/aspirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device
'Proper use' is defined as successfully completing all of the following five steps:
- Attaching wash-head to handle properly
- Positioning child correctly for procedure as per the user manual's instructions
- Using the device's control button correctly for both irrigation and aspiration
- Placing the wash-head tip correctly at the nasal opening
- Using the device for up to but not exceeding five seconds
Measured: Day one, immediately
Secondary outcomes (5)
Number of Participants Who Experienced Ease of Use With the Device
After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.
The question and scale are as follows: How easy was the device to use?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy
Measured: Day one, immediately
Number of Participants Who Found the Device to be Effective
After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.
The question and scale are as follows: How well did the device remove nasal secretions?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy
Measured: Day one, immediately
Number of Participants Who Identified the Device's User Manual as Easy to Understand
After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.
The question and scale are as follows: How easy was the manual to understand?
1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy
Measured: Day one, immediately
Number of Patients Who Were Observed to Have an Adverse Event
While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:
- bloody nose
- being sprayed in the eye with the saline
- vomiting after the procedure
- choking during or after the procedure
- other
Measured: Day one, immediately
Number of Patients Experiencing a Physical Injury During Use
After the procedure, the patient was directly examined for any of the following:
- bleeding from the nostrils
- disruption of the skin around the nose
- increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)
Measured: Day one, immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aardvark Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Schwartz, MD, Principal investigator, Advanced Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129765
- Sponsor's protocol ID
- AM-002
- Status last verified
- Jul 2010
- First submitted
- 21 May 2010
- Last updated
- 3 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Usability of a Nasal Lavage System in Children
- ClinicalTrials.gov ID
- NCT01129765
- Acronym / sponsor ID
- AM-002
- Keywords
- Nasal suction, Nasal aspiration, Nasal saline irrigation, Nasal lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aardvark Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Posted 5 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use.
Detailed description
Nasal congestion is an important complication of viral upper respiratory infections in young children. It can lead to poor eating, sleeping and breathing. Recently, the FDA recommended against using over-the-counter cold remedies in young children because of inefficacy and occasional dangerous side effects. A commonly recommended non-drug solution for nasal congestion is nasal suctioning. This can be effective but currently available methods have been found to be awkward, uncomfortable and ineffective.
The studied device has potential for making nasal suctioning easy to perform in the home setting, especially in young children. It is already FDA cleared for professional use and this study was developed to demonstrate that it is appropriate for the home as well. This would be significant as it would allow parents a strategy of clearing their child's nose without drugs.
The device is automatic and handheld that can irrigate and/or aspirate the nasal cavity with hospital-grade suction. The handle houses a pump that can achieve air flows known to be effective for infant nasal suctioning in the hospital. A disposable wash-head is placed on top. It has an irrigation chamber with 0.9% saline and another chamber for collecting the aspirated nasal contents. The unit operates from a single bi-functional button.
Several key safety features have been built in such as: a tip that is shaped to maximize the seal but prevent intrusion into the nose; an irrigation function that delivers an optimal volume but prevents flooding the nasal cavity; and a pump that can deliver suction known to be effective in the hospital but whose safety valve does not allow it to rise above dangerous levels.
Participants were parents of children who have nasal congestion for whom nasal suctioning is traditionally recommended. They were asked to review the instruction manual of the device, and then use it on their children.
The primary outcome was proper use of device that was precisely defined. Additionally, subjective efficacy of mucus removal, evidence of adverse events and understanding of the device's user manual were also measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of congested children | – | Device: Use of an automatic nasal irrigator/aspiratorParents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The participants were selected from a primary care pediatric clinic.
Key inclusion criteria (1 listed)
- Parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed.
Key exclusion criteria (2 listed)
- Parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning.
- Additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of an automatic nasal irrigator/aspiratorAlso: Nasal aspiration, Nasal irrigation, Nasal lavageAfter reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events. | Device | Parents of congested children |
Primary outcome
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device
Time frame: Day one, immediately
'Proper use' is defined as successfully completing all of the following five steps: 1. Attaching wash-head to handle properly 2. Positioning child correctly for procedure as per the user manual's instructions 3. Using the device's control button correctly for both irrigation and aspiration 4. Placing the wash-head tip correctly at the nasal opening 5. Using the device for up to but not exceeding five seconds
5 secondary outcomes
Number of Participants Who Experienced Ease of Use With the Device
Time frame: Day one, immediately
Number of Participants Who Found the Device to be Effective
Time frame: Day one, immediately
Number of Participants Who Identified the Device's User Manual as Easy to Understand
Time frame: Day one, immediately
Number of Patients Who Were Observed to Have an Adverse Event
Time frame: Day one, immediately
Number of Patients Experiencing a Physical Injury During Use
Time frame: Day one, immediately
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Schwartz, MD principal investigator
Advanced Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Congestion and Respiratory Tract Infection, run by Aardvark Medical Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device (time frame: Day one, immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2010.