{"title":"阿莫达非尼对中重度阻塞性睡眠呼吸暂停患者持续气道正压治疗后白天嗜睡的疗效：一项前瞻性研究","authors":"Jinjuta Ngeyvijit, Tayard Desudchit, Nattapot Dadphan, Pantaree Aswanetmanee, Dittapol Muntham, Naricha Chirakalwasan","doi":"10.1007/s11325-025-03448-3","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Armodafinil has been approved for treating excessive daytime sleepiness (EDS) in OSA patients who still experience EDS after adequately treated with CPAP. However, the effectiveness of armodafinil administration in OSA patients with suboptimal CPAP usage and persistent EDS remains unexplored.</p><p><strong>Method: </strong>A 12-week prospective cohort study enrolled 33 moderate to severe OSA patients with suboptimal CPAP usage (2- < 4 h/night) who experienced EDS and were naïve to armodafinil. Patients received daily 150 mg of armodafinil and continued using CPAP. Efficacy and adverse events were evaluated.</p><p><strong>Results: </strong>A total of 30 patients with mean age of 45.10 ± 10.74 years and Epworth sleepiness scale (ESS) of 13.93 ± 3.16 completed the study; however, one participant completed only the 8-week follow-up. After 12 weeks, ESS was significantly decreased by 5.03 ± 4.22 (p < 0.001). Clinical global impression (CGI) rated by investigators and by participants was significantly decreased by 1.79 ± 0.72 (p < 0.001) and 1.93 ± 0.75 (p < 0.001); respectively. Pittsburgh sleep quality index (PSQI) was significantly decreased by 5.27 ± 2.93 (p < 0.001). The OSLER error index did not significantly improved (p = 0.61); however, a trend toward improvement was observed in patients with baseline psychomotor vigilance impairment (p = 0.17). While CPAP adherence showed no statistically significant change, there was a trend toward improvement from 2.99 ± 0.63 h/night at baseline to 3.47 ± 1.38 h/night (p = 0.09). No serious side effects were observed.</p><p><strong>Conclusion: </strong>In moderate to severe OSA patients with suboptimal CPAP usage who still experience EDS, administering armodafinil over 12 weeks period significantly improved EDS and sleep quality subjectively without compromising CPAP adherence. Armodafinil demonstrated excellent tolerability with self-limiting side effects.</p>","PeriodicalId":520777,"journal":{"name":"Sleep & breathing = Schlaf & Atmung","volume":"29 5","pages":"280"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy of armodafinil in moderate to severe obstructive sleep apnea patients with excessive daytime sleepiness after suboptimal usage of continuous positive airway pressure treatment: a prospective study.\",\"authors\":\"Jinjuta Ngeyvijit, Tayard Desudchit, Nattapot Dadphan, Pantaree Aswanetmanee, Dittapol Muntham, Naricha Chirakalwasan\",\"doi\":\"10.1007/s11325-025-03448-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Armodafinil has been approved for treating excessive daytime sleepiness (EDS) in OSA patients who still experience EDS after adequately treated with CPAP. However, the effectiveness of armodafinil administration in OSA patients with suboptimal CPAP usage and persistent EDS remains unexplored.</p><p><strong>Method: </strong>A 12-week prospective cohort study enrolled 33 moderate to severe OSA patients with suboptimal CPAP usage (2- < 4 h/night) who experienced EDS and were naïve to armodafinil. Patients received daily 150 mg of armodafinil and continued using CPAP. Efficacy and adverse events were evaluated.</p><p><strong>Results: </strong>A total of 30 patients with mean age of 45.10 ± 10.74 years and Epworth sleepiness scale (ESS) of 13.93 ± 3.16 completed the study; however, one participant completed only the 8-week follow-up. After 12 weeks, ESS was significantly decreased by 5.03 ± 4.22 (p < 0.001). Clinical global impression (CGI) rated by investigators and by participants was significantly decreased by 1.79 ± 0.72 (p < 0.001) and 1.93 ± 0.75 (p < 0.001); respectively. Pittsburgh sleep quality index (PSQI) was significantly decreased by 5.27 ± 2.93 (p < 0.001). The OSLER error index did not significantly improved (p = 0.61); however, a trend toward improvement was observed in patients with baseline psychomotor vigilance impairment (p = 0.17). While CPAP adherence showed no statistically significant change, there was a trend toward improvement from 2.99 ± 0.63 h/night at baseline to 3.47 ± 1.38 h/night (p = 0.09). No serious side effects were observed.</p><p><strong>Conclusion: </strong>In moderate to severe OSA patients with suboptimal CPAP usage who still experience EDS, administering armodafinil over 12 weeks period significantly improved EDS and sleep quality subjectively without compromising CPAP adherence. Armodafinil demonstrated excellent tolerability with self-limiting side effects.</p>\",\"PeriodicalId\":520777,\"journal\":{\"name\":\"Sleep & breathing = Schlaf & Atmung\",\"volume\":\"29 5\",\"pages\":\"280\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-09-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Sleep & breathing = Schlaf & Atmung\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s11325-025-03448-3\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sleep & breathing = Schlaf & Atmung","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s11325-025-03448-3","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Efficacy of armodafinil in moderate to severe obstructive sleep apnea patients with excessive daytime sleepiness after suboptimal usage of continuous positive airway pressure treatment: a prospective study.
Purpose: Armodafinil has been approved for treating excessive daytime sleepiness (EDS) in OSA patients who still experience EDS after adequately treated with CPAP. However, the effectiveness of armodafinil administration in OSA patients with suboptimal CPAP usage and persistent EDS remains unexplored.
Method: A 12-week prospective cohort study enrolled 33 moderate to severe OSA patients with suboptimal CPAP usage (2- < 4 h/night) who experienced EDS and were naïve to armodafinil. Patients received daily 150 mg of armodafinil and continued using CPAP. Efficacy and adverse events were evaluated.
Results: A total of 30 patients with mean age of 45.10 ± 10.74 years and Epworth sleepiness scale (ESS) of 13.93 ± 3.16 completed the study; however, one participant completed only the 8-week follow-up. After 12 weeks, ESS was significantly decreased by 5.03 ± 4.22 (p < 0.001). Clinical global impression (CGI) rated by investigators and by participants was significantly decreased by 1.79 ± 0.72 (p < 0.001) and 1.93 ± 0.75 (p < 0.001); respectively. Pittsburgh sleep quality index (PSQI) was significantly decreased by 5.27 ± 2.93 (p < 0.001). The OSLER error index did not significantly improved (p = 0.61); however, a trend toward improvement was observed in patients with baseline psychomotor vigilance impairment (p = 0.17). While CPAP adherence showed no statistically significant change, there was a trend toward improvement from 2.99 ± 0.63 h/night at baseline to 3.47 ± 1.38 h/night (p = 0.09). No serious side effects were observed.
Conclusion: In moderate to severe OSA patients with suboptimal CPAP usage who still experience EDS, administering armodafinil over 12 weeks period significantly improved EDS and sleep quality subjectively without compromising CPAP adherence. Armodafinil demonstrated excellent tolerability with self-limiting side effects.
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