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Observational Study
. 2024 Sep 6;25(1):331.
doi: 10.1186/s12931-024-02965-1.

Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study

Celia Vidal  1   2 , Fanny Bertelli  2 , Jean-Pierre Mallet  2   3   4 , Raphael Gilson  2 , Jean-Christian Borel  5 , Frédéric Gagnadoux  6 , Arnaud Bourdin  2   3   4 , Nicolas Molinari  1   2 , Dany Jaffuel  7   8   9
Affiliations
Observational Study

Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study

Celia Vidal et al. Respir Res. .

Abstract

Background: Over the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP.

Methods: The InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender.

Results: A total of 1484 patients treated for a median duration of 4.4 years (IQ25-75: 2.0-9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence.

Conclusion: In real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence.

Trial registration: INTERFACEVENT IS REGISTERED WITH CLINICALTRIALS.GOV (NCT03013283).FIRST REGISTRATION DATE IS 2016-12-23.

Keywords: Leaks; Side-effects; Sleep apnea; Women.

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Conflict of interest statement

CV declares working for Adene home healthcare provider company. JPM declares grants/funds: Adene, Novartis, Chiesy, GSK, DPC-ORL; personal fees from Pulmon X. RG declares working for Adene home healthcare provider company. JCB declares consultant fees from AGIR à dom, a French Homecare provider. FG declares receipt of personal fees from AIR LIQUIDE SANTE, INSPIRE, BIOPROJET, RESMED and SEFAM; payment for presentations from BIOPROJET, CIDELEC, INSPIRE, RESMED, and SEFAM; non-financial support from ASTEN SANTE. AB declares grants/funds: Boehringer Ingelheim; personal fees: AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi-Regeneron; clinical trial investigator: Acceleron, Actelion, Galapagos, Merck Sharpe & Dohme, Nuvaira, Pulmonx, United Therapeutic, Celltrion, Vertex. NM declares grants/funds: GlaxoSmithKline; personal fees: Sanofi-Regeneron. DJ reports personal fees from Lowenstein, Jazz, Bioprojet, Adene, Bastide, LVL, GSK, Astra, ALK, Bohringer Ingelheim, Sanofi, Philips Healthcare, and Resmed, personal fees and nonfinancial support from Sefam and Nomics, grants and personal fees from Novartis, outside the submitted work.

Figures

Fig. 1
Fig. 1
CPAP-usage (a) and CPAP-non-adherence (b) according to maks type and gender
Fig. 2
Fig. 2
Visual analogue scales for mask related side-effect scores according to gender and mask type
See this image and copyright information in PMC

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