Amara Full Face Mask Evaluation - Cheap CPAP Supplies

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Amara Full Face Mask Evaluation Authors: Steve Coughlin, Mark Haycock, Joanna Scott. Philips Home Healthcare Solutions. Introduction The mask is a crucial aspect of Continuous Positive Airway Pressure (CPAP) treatment acceptance. Common reasons for non-adherence include pressure intolerance and issues related to the mask, such as facial discomfort, skin injury and significant air leaks1. The efficacy of CPAP relies on the patient’s ability to use this system for the duration of their sleep. Research has shown that compliance is variable, with about 25% of patients discontinuing therapy within the first year2 . Additionally, only 50% of patients use it consistently for an average of 6 hours every night, with the other 50% using it periodically with a mean compliance of 3.5 hours per night3. Side effects to the mask are often cited as causes of poor CPAP compliance4. For example, a poorly fitting mask can sometimes lead to the patient periodically abandoning therapy because of pressure sores on the face. Similarly, an excessive mask leak can reduce the ability of the device to provide an effective treatment. Size, weight and comfort are also important as the patient has to wear the mask for several hours each night. Other features such as ease of use and handling may also play a role. Accordingly, manufacturers are now concentrating their efforts on producing masks that are easy to use and appealing without compromising on performance. This evaluation was carried out to assess the new Amara full-face mask produced by Philips Respironics. The Amara was designed to optimize ease of use, performance and appeal with the intention of reducing the level of intimidation sometimes experienced by PAP naive patients as well as maximizing their levels of comfort and seal during therapy. Methodology Fifty-one clinically stable, established full face mask CPAP patients from Australia were randomly asked to trial the Amara Full Face mask with their existing CPAP device for a 2-week period during the months of October to December 2012. Mask fitting and patient education were performed by experienced personnel routinely working in local DME outlets.

Patients completed a questionnaire at baseline (Baseline Questionnaire), which asked them questions about their usual mask. They then completed a matched questionnaire upon completion of the Amara evaluation (Amara Questionnaire). Questionnaires focused on comfort, performance and ease of use of the patient's mask, and quality of sleep. The majority of questions utilized a five point Likert scale containing the ratings: Agree, Strongly Agree, Neither Agree nor Disagree, Disagree, and Strongly Disagree. For ease of interpretation, Likert Scale data were grouped into three new categories. Ratings of Agree and Strongly Agree were grouped into a new category called Agree. Ratings of Disagree and Strongly Disagree were grouped into a new category called Disagree. Ratings of Neither Agree nor Disagree were renamed as neutral.

Results All masks at baseline (n=51) Headgear comfortable?

Baseline Questionnaire Amara Questionnaire

Quattro mask at baseline (n=27) Neutral (%)

Agree (%) 56.9 86.3

Disagree (%)

Headgear comfortable?

23.5 3.9 9.8

Baseline Questionnaire Amara Questionnaire

27.5 11.8

Baseline Questionnaire Amara Questionnaire

37.3 19.6

Baseline Questionnaire Amara Questionnaire

52.9 13.7

Baseline Questionnaire Amara Questionnaire

21.6 5.9 2.0/2.0

Baseline Questionnaire Amara Questionnaire

19.6

Mask comfortable?

Baseline Questionnaire Amara Questionnaire

21.6 15.7

25.5

21.6

Baseline Questionnaire Amara Questionnaire

15.7 11.8/ 2.0

Baseline Questionnaire Amara Questionnaire

88.2 82.4

5.9/5.9 7.8 9.8

Baseline Questionnaire Amara Questionnaire

90.2 94.1

3.9/ 5.9 2.0/ 3.9

Baseline Questionnaire Amara Questionnaire

17.6 9.8/ 3.9

Baseline Questionnaire Amara Questionnaire

43.1

63.0 14.8

33.3 22.2

70.4 96.3

7.4 3.7/ 0

29.6

51.9 85.2

18.5 11.1/ 3.7

40.7

14.8 25.9

44.4 25.9

48.1

88.9 81.5

7.4/ 3.7 11.1 7.4

88.9 100

7.4/3.7 0/0 7.4

70.4 85.2

22.2 11.1/ 3.7

Sleep well with mask? 25.5 11.8

Baseline Questionnaire Amara Questionnaire

15.7

31.4 17.6

Baseline Questionnaire Amara Questionnaire

80

100

15.7 25.5

58.8 62.7

Satisfied with mask?

Baseline Questionnaire Amara Questionnaire

25.9

Easy to clean? 5.9

76.5 86.3

Sleep well with mask?

Baseline Questionnaire Amara Questionnaire

11.1 51.9

63 14.8

33.3

Easy to disassemble?

Easy to clean?

Baseline Questionnaire Amara Questionnaire

25.9

Easy to fit?

Easy to disassemble?

Baseline Questionnaire Amara Questionnaire

11.1 51.9

Aesthetically pleasing? 49.0 25.5

33.3

17.6 31.4

Easy to fit?

Baseline Questionnaire Amara Questionnaire

22.2 7.4

18.5

Clear field of vision? 21.6

62.7 86.3

Aesthetically pleasing?

Baseline Questionnaire Amara Questionnaire

22.2

Light? 72.5 96.1

Clear field of vision?

Baseline Questionnaire Amara Questionnaire

55.6 74.1

Is small? 21.6

25.5 64.7

Light?

Baseline Questionnaire Amara Questionnaire

25.9 3.7/11.1

Good Seal? 27.5

35.3 54.9

Is small?

Baseline Questionnaire Amara Questionnaire

Disagree (%) 11.1

Mask comfortable? 51.0 72.5

Good Seal?

Baseline Questionnaire Amara Questionnaire

Neutral (%)

Agree (%) 63 85.2

11.1 25.9

63.0 63.0

25.9 11.1

Satisfied with mask? 19.6

49.0 66.7

0

20

40

60

0

20

40

0

No (%) 35.3

Yes (%) 64.7

Keep Mask

Amara Questionnaire

60

80

Conclusion

20

40

60

0

20

40

11.1

29.6 18.5

80

100

No (%) 37.0

Yes (%) 63.0

Keep Mask

Amara Questionnaire 100

14.8

55.6 70.4

60

80

100

References

The Amara full face mask achieves its design goals of being an easy to use and highly appealing full face mask, when compared to established ‘CPAP users’ usual masks. When selecting only people who used the Quattro full face mask (27 ) as their usual mask, the Amara achieved superior scores in the areas of performance, appeal, overall satisfaction and certain attributes of ease of use. Upon completion of the two week evaluation period, approximately two thirds of existing CPAP users preferred to keep the Amara full face mask as their mask of choice.

E lliott M. The interface: crucial for successful non invasive ventilation Eur Respir J 2004; 23:7–8. (2) McArdle N, Devereux G, Heidarnejad H, et al. Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med 1999; 159:1108-1114. (3) Weaver TE, Kribbs NB, Pack AI, et al. Night-to-night variability in CPAP use over the first three months of treatment. Sleep 1997; 20:278-283. (4) E ngleman HM, Martin SE, Douglas NJ. Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Thorax 1994; 49:263-266. (1)

Amara is a trademark of Respironics, Inc. and its affiliates

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