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Study of the Usability and Efficacy of a New Pediatric CPAP Mask

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01312948
First received: February 6, 2011
Last updated: April 9, 2012
Last verified: August 2011
History of Changes
  Purpose

This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged 2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV) treatment. The participants will undergo a monitored sleep study, followed by a 7 night trial of the Pixi mask in the home environment. During the study usability will be measured through questionnaires filled in by the parent and clinician.

The study hypothesis is that the usability of the mask will be superior to the patient's usual mask.


Condition Intervention
Obstructive Sleep Apnea
Respiratory Insufficiency
 Device: Prototype mask (known as Pixi)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pediatric Nasal Mask (Pixi) Usability Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:
  • Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask [ Time Frame: 8 nights use ] [ Designated as safety issue: No ]

    Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.

    Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability.



Secondary Outcome Measures:
  • Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask [ Time Frame: >4 hours monitored sleep study ] [ Designated as safety issue: No ]
    Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. 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 patients usual mask


Enrollment: 6
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prototype mask Device: Prototype mask (known as Pixi)
This is a prototype mask to be used with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) therapy. The mask attaches to the face, covering the nose, and is kept in place with headgear. Therapy is delivered through the mask via a tube which attaches to the CPAP or NIV device.
Other Name: ResMed Pixi paediatric mask

Detailed Description:

This is a prospective, single group, un-blinded study sponsored by ResMed Ltd to investigate the usability of the ResMed Pediatric Nasal Mask (Pixi).

Patients will be recruited from the study site's database. Parents/ guardians of patients who meet the selection criteria and voluntarily agree to participate in the study will be approached by the investigative team to obtain informed consent.

Patients will attend the clinic where baseline information will be collected, including information about the patient's current therapy and data from their last PSG study. Information will be recorded on case report forms (CRF's). Data from the patient's current device will be downloaded during this visit. At this time the Pixi mask will be fitted and adjusted until it is comfortable for the child. The patient's device will be switched to a ResMed VPAP III ST-A with QuickNav if they are not already using one. The VPAP III ST-A with QuickNav will be used in the same mode (CPAP or Bi-level) as the patient's current device.

The participants will undergo a monitored PSG study on the first night of the trial. They will use the Pixi mask and the VPAP III ST-A with QuickNav during this PSG. The initial therapy settings will be based on the child's usual therapy, with any therapy setting modifications made as clinically required during the PSG.

Patients will then use the Pixi mask with the VPAP III ST-A with QuickNav in the home environment for 7 nights. After using the mask in the home environment, the child's legal guardian will rate their satisfaction with the Pixi mask as compared to the child's current mask. The child will also be asked to evaluate the mask if they are able.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is between 2-7 years of age
  • Is a current PAP (Bi-level or CPAP) therapy user, defined as being on PAP therapy for at least 1 month prior to study entry
  • Is a current user of a nasal mask
  • Legal guardian can read and comprehend English
  • Legal guardian is willing to give written informed consent

Exclusion Criteria:

  • Recent sinus surgery (within 6 weeks of study entry)
  • Concurrent participation in other clinical trials
  • History of clinically significant epistaxis in the past 6 months
  • Known co-morbidities that, per clinical judgment, would prevent compliance to therapy
  • Other reasons for non-compliance that affect subject's ability to use therapy such as primary claustrophobia
  • Significant cardiac disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312948

Locations
Australia, Queensland
Mater Children's Hospital
Brisbane, Queensland, Australia, 4101
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Margaret-Anne Harris, MBBS, FRACP Mater Children's Hospital
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01312948     History of Changes
Other Study ID Numbers: MA13122010
Study First Received: February 6, 2011
Results First Received: October 31, 2011
Last Updated: April 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by ResMed:
Obstructive sleep apnea
OSA
CPAP
 CPAP mask
Non-invasive ventilation
NIV

Additional relevant MeSH terms:
Apnea
Respiratory Insufficiency
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013