Obstructive Sleep ApneaNCT01154322
Pediatric Nasal Mask Usability Study
A study testing Pixi pediatric mask in people with Obstructive Sleep Apnea, run by ResMed at 3 sites in United States.
Trial summary
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Pixi pediatric mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Nov 2011
- Phase
- Interventional
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 2-7 years of age
- Diagnosis of OSA
- Current PAP therapy user
- Current nasal mask user
Who cannot join
- Recent sinus surgery
- Allergies to mask material
- Current seasonal allergies that could interfere with therapy
- History of clinically significant epistaxis in past 6 months
- Upper airway surgery less than 60 days before study entry
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Children's Hopsital
Aurora, Colorado, 80045
Stanford Center for Human Sleep Research
Redwood City, California, 94063
Gaylord Sleep Medicine
Wallingford, Connecticut, 06492
About this study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
Read the detailed description
Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse of the upper airway during sleep. Features of OSA include snoring to upper airway resistance, which could be mild to severe. While OSA has been studied extensively in an adult population, research indicates that OSA is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. The study seeks to determine if a mask made for a pediatric population effectively treats their OSA.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Pixi pediatric mask
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pixi pediatric maskDevice
The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric mask | Experimental | Not described Receives: Device: Pixi pediatric mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.
Measured: Baseline AHI
Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.
Measured: AHI after min 21 days use with Pixi mask
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionNov 2011
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 Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154322
- Sponsor's protocol ID
- MA-09-09
- Status last verified
- Jan 2013
- First submitted
- 15 Jun 2010
- Last updated
- 24 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Nasal Mask Usability Study
- ClinicalTrials.gov ID
- NCT01154322
- Acronym / sponsor ID
- MA-09-09
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 16 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
Detailed description
Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse of the upper airway during sleep. Features of OSA include snoring to upper airway resistance, which could be mild to severe. While OSA has been studied extensively in an adult population, research indicates that OSA is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. The study seeks to determine if a mask made for a pediatric population effectively treats their OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric mask | Experimental | Device: Pixi pediatric mask |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 2-7 years of age
- Diagnosis of OSA
- Current PAP therapy user
- Current nasal mask user
Key exclusion criteria (5 listed)
- Recent sinus surgery
- Allergies to mask material
- Current seasonal allergies that could interfere with therapy
- History of clinically significant epistaxis in past 6 months
- Upper airway surgery less than 60 days before study entry
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 |
|---|---|---|
| Pixi pediatric maskThe study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study. | Device | Pediatric mask |
Primary outcome
Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Time frame: Baseline AHI
Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.
Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Time frame: AHI after min 21 days use with Pixi mask
Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe >30). In clinical practice an AHI <5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pixi pediatric mask in people with Obstructive Sleep Apnea, run by ResMed at 3 sites 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 4 inclusion and 5 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 16 Jan 2013). 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?
Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask (time frame: Baseline AHI). The study lists 2 primary outcomes in all. 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 24 Jan 2013.