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

ResMed

Status

Completed

Conditions

Respiratory Insufficiency

Obstructive Sleep Apnea

Treatments

Device: Prototype mask (known as Pixi)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01312948

MA13122010

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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