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 for 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: <a href="https://anzctr.org.au/Trial/Registration/TrialReview.aspx%3Fid=382142">https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382142</a>; Identifier: ACTRN12621001301853. Citation: Tong BK, Cistulli PA, Ledger S, Chan ASL. A novel three-dimensional-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2025;21(1):9–16.

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

期刊论文
发表日期：

2025年1月1日

查看全文

Benjamin K. Tong,
Peter A. Cistulli,
Susan Ledger,
Andrew S. L. Chan

摘要

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 for 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.

Citation:

Tong BK, Cistulli PA, Ledger S, Chan ASL. A novel three-dimensional-printed customized nasal mask for improving CPAP adherence and satisfaction for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2025;21(1):9–16.