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Purpose <p>To evaluate the effectiveness and treatment acceptance of a novel, self-titratable interlocking mandibular advancement device (KKU-MAD), fabricated using a fully digital, single-visit workflow, for managing obstructive sleep apnea (OSA).</p> Methods <p>This prospective clinical study enrolled adults diagnosed with mild to moderate OSA. Each received a customized KKU-MAD and underwent a 1- to 2-month acclimatization and titration period, starting with 50% mandibular protrusion and adjusted based on subjective improvements in snoring and daytime sleepiness, without unacceptable discomfort. Sleep parameters were assessed using a home sleep apnea test (HSAT). Patient-reported outcomes—including sleepiness, quality of life, treatment adherence, satisfaction, and side effects—were evaluated at baseline and post-treatment.</p> Results <p>Twenty-one participants (8 women, 13 men) completed the study. Significant improvements (<i>p</i> &lt; 0.05) were observed in respiratory event index (REI: 14.7 ± 1.6 to 9.4 ± 1.3), supine REI (19.2 ± 1.9 to 11.0 ± 1.2), oxygen desaturation index (15.7 ± 1.9 to 9.8 ± 1.3), and percentage of snoring (23.7 ± 3.6 to 17.1 ± 3.8) (Mean ± SE). The Short Form-36 Health Survey showed significant improvement (<i>p</i> &lt; 0.05) in role limitations due to physical and mental health domains. Participants used the device on average 7.3&#xa0;h/night and 5.5 nights/week. Patient satisfaction was high (NRS 8.8 ± 1.3), with all participants continuing use of the device beyond the study period. Reported side effects were mild, transient, and did not lead to discontinuation.</p> Conclusion <p>The KKU-MAD demonstrated significant improvements in sleep parameters, along with high patient adherence and satisfaction. Its fully digital, single-visit workflow reduces production time and offers practical and cost-effective alternative for OSA treatment.</p> Clinical trial registration number: <p>UMIN Clinical Trial Registry: UMIN000056614</p> <p>Date of registration: 2/1/2025</p> <p>Retrospectively registered</p>

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Effectiveness of a novel one visit 3D-printed titratable interlocking mandibular advancement device for patients with obstructive sleep apnea

  • 期刊论文

  • 发表日期：

    2025年10月11日

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  • Cattliya Laohapotjanart,
  • Jarin Paphangkorakit,
  • Teekayu Plangkoon Jorns,
  • Apichart So-ngern,
  • Supawan Laohasiriwong,
  • Kittisak Sawanyawisuth,
  • Rajda Chaichit,
  • Poonsak Pisek,
  • Supanigar Ruangsri

摘要

Purpose

To evaluate the effectiveness and treatment acceptance of a novel, self-titratable interlocking mandibular advancement device (KKU-MAD), fabricated using a fully digital, single-visit workflow, for managing obstructive sleep apnea (OSA).

Methods

This prospective clinical study enrolled adults diagnosed with mild to moderate OSA. Each received a customized KKU-MAD and underwent a 1- to 2-month acclimatization and titration period, starting with 50% mandibular protrusion and adjusted based on subjective improvements in snoring and daytime sleepiness, without unacceptable discomfort. Sleep parameters were assessed using a home sleep apnea test (HSAT). Patient-reported outcomes—including sleepiness, quality of life, treatment adherence, satisfaction, and side effects—were evaluated at baseline and post-treatment.

Results

Twenty-one participants (8 women, 13 men) completed the study. Significant improvements (p < 0.05) were observed in respiratory event index (REI: 14.7 ± 1.6 to 9.4 ± 1.3), supine REI (19.2 ± 1.9 to 11.0 ± 1.2), oxygen desaturation index (15.7 ± 1.9 to 9.8 ± 1.3), and percentage of snoring (23.7 ± 3.6 to 17.1 ± 3.8) (Mean ± SE). The Short Form-36 Health Survey showed significant improvement (p < 0.05) in role limitations due to physical and mental health domains. Participants used the device on average 7.3 h/night and 5.5 nights/week. Patient satisfaction was high (NRS 8.8 ± 1.3), with all participants continuing use of the device beyond the study period. Reported side effects were mild, transient, and did not lead to discontinuation.

Conclusion

The KKU-MAD demonstrated significant improvements in sleep parameters, along with high patient adherence and satisfaction. Its fully digital, single-visit workflow reduces production time and offers practical and cost-effective alternative for OSA treatment.

Clinical trial registration number:

UMIN Clinical Trial Registry: UMIN000056614

Date of registration: 2/1/2025

Retrospectively registered