A novel three-dimensional-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea

Study Objectives: To evaluate the performance of a novel three-dimensional-printed customized nasal mask on patient satisfaction and adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea. Methods: Patients prescribed CPAP therapy with suboptimal CPAP adherence using a conventional CPAP mask (< 70% of nights with >= 4 hours per night over 4 weeks) were recruited from the sleep investigation unit of a tertiary hospital. Patients underwent a three-dimensional facial mapping procedure to have a novel three-dimensional-printed customized nasal mask fabricated which was trialed four weeks. CPAP adherence data download of the same period was conducted with their pre-existing conventional mask and customized mask. Questionnaires assessing symptoms of obstructive sleep apnea and mask-related side-effects were administered before and after the trial of the customized mask. Results: Thirty patients (22 males and 8 females, age 63.3 +/- 12.5 years, body mass index 31.7 +/- 5.2 kg/m2, apnea-hypopnea index 37.3 +/- 21.9 events/h [mean +/- standard deviation]) were studied. CPAP was used in a greater proportion of nights with the customized mask (85.7 [66.1, 98.2]% vs 63.2 [13.1, 96.8]%, P = .009) compared to the conventional mask. Hourly CPAP usage was higher with the customized mask (3.8 [2.7, 5.8] hours vs 2.4 [0.3, 5.0] hours, P = .016) compared to a conventional mask. Patients preferred the customized mask (P = .008) and reported less mask-related side effects. Conclusions: The novel three-dimensional-printed customized mask improved CPAP usage in patients with suboptimal CPAP adherence. Customized CPAP masks may be a suitable option for patients experiencing poor CPAP adherence from mask-related side effects. Clinical Trial Registration: Registry: ANZCTR; Name: Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A; URL: https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382142; Identifier: ACTRN12621001301853.