| Clinical efficacy study of position-responding mandibular advancement device in patients with obstructive sleep apnea |
Sung-Woon On1
, Dong-Kyu Kim2,3,4
, Min Hyuk Lee5
, Ji Hae Lee6
, Kyung Chul Lee5
, Soo-Hwan Byun7
, Seok Jin Hong5
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1Division of Oral and Maxillofacial Surgery, Department of Dentistry, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Republic of Korea
2Department of Otorhinolaryngology-Head and Neck Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea
3Institute of New Frontier Research, Division of Big Data and Artificial Intelligence, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea
4OUaR LaB, Inc, Seoul, Republic of Korea
5Department of Otorhinolaryngology-Head and Neck Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
6Department of Otorhinolaryngology-Head and Neck Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Dongtan, Republic of Korea
7Department of Oral & Maxillofacial Surgery, Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea |
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Received: April 29, 2024; Revised: August 11, 2024 Accepted: August 29, 2024. Published online: August 29, 2024.
*Sung-Woon On and Dong-Kyu Kim contributed equally to this work. |
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| ABSTRACT |
Objectives
Although mandibular advancement device (MAD) treatment is effective in patients with obstructive sleep apnea (OSA), there are still some concerns about its potential therapeutic and side effects. Thus, we developed a novel MAD that auto-titrates depending on its position in patients with OSA. Therefore, we conducted a clinical trial to determine the efficacy of an auto-titrating mandibular advancement device (AMAD) for treating OSA.
Methods
Fourteen patients with OSA were enrolled in this study. Polysomnography (PSG) was conducted at the start of the clinical trial, and PSG with AMAD in situ was performed after three months of treatment.
Results
The mean Epworth Sleepiness Scale (ESS) and STOP-Bang scores were 8.21 ± 4.21 and 5.00 ± 1.00, respectively. After 3 months of treating AMAD, STOP-Bang scores improved to 3.75 ± 1.06; however, there was no significant change in ESS scores. Additionally, we found statistically significant improvements in several respiratory parameters in the PSG data after AMAD treatment. The AHI (32.85 ± 21.71 to 12.93 ± 10.70), supine AHI (45.91 ± 23.58 to 15.59 ± 12.76), lateral AHI (13.94 ± 10.95 to .49 ± 7.40), lowest O2 saturation (79.71 ± 6.22 to 84.00 ± 5.71), total arousal number (191.14 ± 112.07 to 86.57 ± 48.80), and arousal index (33.76 ± 21.00 to 15.05 ± 8.42) were recorded. However, there were no significant changes in total sleep time, sleep efficiency, or mean oxygen saturation. Additionally, we did not observe any major side effects during treatment, specifically related to tooth or jaw pain.
Conclusion
Our clinical trial revealed that AMAD improved PSG parameters and reduced the incidence of common side effects. Therefore, AMAD may be an effective alternative treatment for OSA. |
| Keywords:
sleep, apnea, obstructive sleep apnea, mandibular advancement device, oral appliance, position |
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