Trial reportSleep & breathing = Schlaf & Atmung2025
Effectiveness of a novel one visit 3D-printed titratable interlocking mandibular advancement device for patients with obstructive sleep apnea.
Trial report in Sleep & breathing = Schlaf & Atmung, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
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Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo 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).
methodsThis 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.
resultsTwenty-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.
conclusionThe 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
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.