Marie-Caroline Rotty1,2, Carey M Suehs3,4, Jean-Pierre Mallet2,3, Christian Martinez2, Jean-Christian Borel5, Claudio Rabec6, Fanny Bertelli1,2, Arnaud Bourdin2,3,7, Nicolas Molinari1,3, Dany Jaffuel8,9,10,11. 1. IMAG, CNRS, Montpellier University, Montpellier University Hospital, Montpellier, France. 2. Apard Groupe Adène, Montpellier, France. 3. Department of Respiratory Diseases, Montpellier University Hospital, Arnaud de Villeneuve Hospital, CHRU Montpellier, 371, Avenue Doyen Giraud, 34295, Montpellier Cedex 5, France. 4. Department of Medical Information, Montpellier University Hospital, Montpellier, France. 5. Inserm U1042, HP2 (Hypoxia PhysioPathology) LaboratoryCentre Hospitalier Universitaire Grenoble Alpes, Grenoble Alps University, Grenoble, France. 6. Pulmonary Department and Respiratory Critical Care Unit, University Hospital Dijon, Dijon, France. 7. PhyMedExp (INSERM U 1046, CNRS UMR9214), Montpellier University, Montpellier, France. 8. Apard Groupe Adène, Montpellier, France. dany.jaffuel@wanadoo.fr. 9. Department of Respiratory Diseases, Montpellier University Hospital, Arnaud de Villeneuve Hospital, CHRU Montpellier, 371, Avenue Doyen Giraud, 34295, Montpellier Cedex 5, France. dany.jaffuel@wanadoo.fr. 10. PhyMedExp (INSERM U 1046, CNRS UMR9214), Montpellier University, Montpellier, France. dany.jaffuel@wanadoo.fr. 11. Pulmonary Disorders and Respiratory Sleep Disorders Unit, Polyclinic Saint-Privat, Boujan sur Libron, France. dany.jaffuel@wanadoo.fr.
Abstract
BACKGROUND: For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term. 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). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS. RESULTS: 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ25-75: 60-74), initial Apnea-Hypopnea-Index (AHI) of 39 (31-56)/h, residual AHIflow was 1.9 (0.9-4) events/h), CPAP-treatment lasted 4.4 (2.0-9.7) years, CPAP-usage was 6.8 (5.5-7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043). CONCLUSION: In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).
BACKGROUND: For some patients, Continuous Positive Airway Pressure (CPAP) remains an uncomfortable therapy despite the constant development of technological innovations. To date, no real life study has investigated the relationship between mask related side-effects (MRSEs) and CPAP-non-adherence (defined as < 4 h/day) or residual-excessive-sleepiness (RES, Epworth-Sleepiness-Scale (ESS) score ≥ 11) in the long-term. 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). MRSEs were evaluated using visual-analogue-scales, CPAP-data using CPAP-software, sleepiness using ESS. RESULTS: 1484 patients were included in the analysis (72.2% male, median age 67 years (IQ25-75: 60-74), initial Apnea-Hypopnea-Index (AHI) of 39 (31-56)/h, residual AHIflow was 1.9 (0.9-4) events/h), CPAP-treatment lasted 4.4 (2.0-9.7) years, CPAP-usage was 6.8 (5.5-7.8) h/day, the prevalence of CPAP-non-adherence was 8.6%, and the prevalence of RES was 16.17%. Leak-related side-effects were the most prevalent side-effects (patient-reported leaks concerned 75.4% of responders and had no correlation with CPAP-reported-leaks). Multivariable logistic regression analyses evaluating explanatory-variable (demographic data, device/mask data and MRSEs) effects on variables-of-interest (CPAP-non-adherence and RES), indicated for patient-MRSEs significant associations between: (i) CPAP-non-adherence and dry-mouth (p = 0.004); (ii) RES and patient-reported leaks (p = 0.007), noisy mask (p < 0.001), dry nose (p < 0.001) and harness pain (p = 0.043). CONCLUSION: In long-term CPAP-treated patients, leak-related side-effects remain the most prevalent side-effects, but patient-reported leaks cannot be predicted by CPAP-reported-leaks. Patient-MRSEs can be independently associated with CPAP-non-adherence and RES, thus implying a complementary role for MRSE questionnaires alongside CPAP-device-reported-data for patient monitoring. Trial registration InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).
Authors: N Meslier; T Lebrun; V Grillier-Lanoir; N Rolland; C Henderick; J C Sailly; J L Racineux Journal: Eur Respir J Date: 1998-07 Impact factor: 16.671
Authors: Emer Van Ryswyk; Craig S Anderson; Nicholas A Antic; Ferran Barbe; Lia Bittencourt; Ruth Freed; Emma Heeley; Zhihong Liu; Kelly A Loffler; Geraldo Lorenzi-Filho; Yuanming Luo; Maria J Masdeu Margalef; R Doug McEvoy; Olga Mediano; Sutapa Mukherjee; Qiong Ou; Richard Woodman; Xilong Zhang; Ching Li Chai-Coetzer Journal: Sleep Date: 2019-10-09 Impact factor: 5.849
Authors: Fanny Bertelli; Carey Meredith Suehs; Jean Pierre Mallet; Marie Caroline Rotty; Jean Louis Pepin; Frédéric Gagnadoux; Eric Matzner-Lober; A Bourdin; Nicolas Molinari; Dany Jaffuel Journal: BMJ Open Date: 2021-05-10 Impact factor: 2.692