ArticleSleep medicine: X2024
Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care.
Article in Sleep medicine: X, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05262439 (Post Market Clinical Follow up of ResMed Mask Systems), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Post Market Clinical Follow up of ResMed Mask Systems
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5 authors.
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Abstract
Purpose: Mask selection could affect an individual's experience with positive airway pressure (PAP) treatment for obstructive sleep apnea, but there is very limited data on the impact of switching to a different mask once established on PAP therapy. This study investigated the patient's experience when switching from a previous-generation PAP mask to a new-generation mask via remote care. Methods: A new-generation mask (AirFit F30i or AirFit N30i) was successfully fitted to 215 participants during video conferencing sessions. Participants completed online questionnaires on day 1, day 3, day 7, day 30 and day 90 after mask switch to collect subjective feedback and quality of life data; objective PAP device data were also downloaded. Results: Residual apnea-hypopnea index showed statistically significant difference from baseline at day 30 (+0.2 ± 0.9/h [p = 0.026]) and day 90 (+0.2 ± 0.8/h [p = 0.006]), however unlikely to be clinically relevant. Average daily usage was significantly increased from baseline at day 30 (+0.2 ± 1.2 h/day [p = 0.010]) but not day 90 (+0.1 ± 1.0 h/day [p = 0.126]). Functional Outcomes of Sleep Questionnaire (FOSQ-10) score was significantly higher at day 90 (change from baseline to day 90: +0.48 ± 2.29 [p = 0.015]). Subjective ratings for comfort, seal, and usability of the new-generation mask were significantly better than the predefined acceptability level. Rates of PAP-related side effects were generally acceptable. Conclusion: Remote management of mask change was associated with good outcomes in terms of objective device data and patient acceptability. This approach could be used to improve the overall therapy experience for individuals requiring a PAP therapy mask change for any reason. Clinical trial registration: http://clinicaltrials.gov (NCT05262439).
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