ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000999639

Ethics application status

Approved

Date submitted

13/08/2014

Date registered

16/09/2014

Date last updated

9/09/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Internal Evaluation of Continuous Positive Airway Pressure Mask Systems in Healthy Volunteers: Comparison of Cushions, Frames, Headgear, Components and Accessories

Scientific title

In healthy volunteers, do novel continuous positive airway
pressure (CPAP) masks, compared to commercially available CPAP masks, improve the subjective comfort, seal, stability, and general usability of CPAP therapy?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Intervention intended for treatment of Obstructive Sleep Apnea (OSA)

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A variety of unregistered prototype CPAP masks will be used as the intervention in this study. The number of intervention masks that an individual participant may test will range from 1 to 2 masks. There will be no washout period between masks. CPAP masks may be full face, nasal, or nasal pillows masks (covering mouth and nose, covering nose only, or inserted into nostrils). Participants will also use an approved CPAP machine and humidifier with the prototype mask. CPAP pressure will be set to 12cmH2O or to a pressure that the participant feels most comfortable. Humidifier settings will be set to a level each participant feels most comfortable with.

As this study protocol aims to facilitate the product development of CPAP masks (an iterative process), this protocol allows for a prototype mask to be designed, used as a trial intervention, improved based on patient feedback, and then retested again as trial intervention. This process may occur for several cycles. This particular protocol also allows for the testing of several different prototype masks. As such, the total number of intervention masks that may be evaluated will not be known at the beginning of the study, but will be reported at the completion of the study.

ResMed teams are constantly designing potential new products. At times it is desirable for internal staff members to volunteer to trial prototypes of masks, frames, headgears and accessories because: employees may wish to assess a design to experience how it works and feels, and determine ways to improve it; there may be a need to gain initial feedback on whether an idea is worth pursuing; design team wishes to narrow down options before proceeding to a user trial on OSA patients.

The sample size is the approximate sample size that will be recruited per prototype trial.
All CPAP masks will be used for a minimum of 3 nights and a maximum of 7 nights each.

Adherence will be monitored through data downloads directly from the patient's device or SD card. Adherence may also be monitored through an approved wireless therapy monitoring system (EasyCare Online).

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The comparator for this study will be one or more of the following:
- commercially available, approved CPAP mask
- another unapproved CPAP mask

The number of intervention masks that an individual participant may test will range from 1 to 2 masks. There will be no washout period between masks.

Control group

Active

Outcomes

Primary outcome [1]

Subjective mask comfort as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)

Timepoint [1]

After maximum of 7 nights on CPAP mask

Primary outcome [2]

Subjective mask seal as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)

Timepoint [2]

After maximum of 7 nights on CPAP mask

Primary outcome [3]

Subjective mask stability as assessed by patient questionnaire (ie. 11-point Likert scale designed for this study)

Timepoint [3]

After maximum of 7 nights on CPAP mask

Secondary outcome [1]

Objective mask efficacy as assessed by CPAP device data

Timepoint [1]