Singh Sameer K, Gu David, Capasso Robson, Liu Stanley, Gouveia Christopher J
Department of Otolaryngology-Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
Department of Otolaryngology-Head and Neck Surgery, Stanford University Medical Center, Stanford, California, U.S.A.
Laryngoscope. 2019 Aug;129(8):1940-1944. doi: 10.1002/lary.27453. Epub 2018 Oct 3.
OBJECTIVES/HYPOTHESIS: Examine US and international clinical trials in obstructive sleep apnea (OSA) to characterize researchers involved, interventions being studied, and opportunities for future investigation.
Retrospective database review.
The information from ClinicalTrials.gov was used to assess OSA clinical trials between 1999 and 2017. Information was gathered on principle investigator (PI) demographics, interventions studied, study funding source, and regional distribution of research institutions.
There were 813 clinical trials studied. The majority of trials examined continuous positive airway pressure interventions (43.7%), with pharmacotherapies being the second most commonly investigated treatment (19.2%). Surgical interventions made up 10.7% (n = 87) of clinical trials for OSA. Most studies were based internationally (59.9%). PIs were predominantly male (72.0%); 72.7% had an MD and 28.6% had a PhD. There were no significant differences in funding source (National Institutes of Health vs. industry, P = .14) or institutional geography (international vs. US, P = .73) between surgical and nonsurgical studies. Surgical trials were significantly more likely to have a male PI and involve pediatric patients compared to nonsurgical trials (P < .001). Otolaryngologists represented 9.2% of all PIs and had similar rates of NIH funding compared to other medical specialists (P = .22).
This study provides a broad overview of past, current, and future treatment paradigms for OSA. Sleep surgery, specifically otolaryngology, is a small voice in the overall landscape of clinical trials for OSA. This information can help guide future research efforts and direct our specialty when setting priorities regarding research funding while encouraging a broad and interdisciplinary pursuit.
NA Laryngoscope, 129:1940-1944, 2019.
目的/假设：审查美国和国际上关于阻塞性睡眠呼吸暂停（OSA）的临床试验，以描述参与研究的人员、正在研究的干预措施以及未来研究的机会。
回顾性数据库审查。
利用ClinicalTrials.gov上的信息评估1999年至2017年间的OSA临床试验。收集了主要研究者（PI）的人口统计学信息、研究的干预措施、研究资金来源以及研究机构的区域分布。
共研究了813项临床试验。大多数试验研究持续气道正压干预措施（43.7%），药物治疗是第二常见的研究治疗方法（19.2%）。手术干预占OSA临床试验的10.7%（n = 87）。大多数研究在国际上开展（59.9%）。PI主要为男性（72.0%）；72.7%拥有医学博士学位，28.6%拥有博士学位。手术和非手术研究在资金来源（美国国立卫生研究院与行业，P = 0.14）或机构地理位置（国际与美国，P = 0.73）方面无显著差异。与非手术试验相比，手术试验的PI更可能为男性且涉及儿科患者（P < 0.001）。耳鼻喉科医生占所有PI的9.2%，与其他医学专科相比，其获得美国国立卫生研究院资助的比例相似（P = 0.22）。
本研究全面概述了OSA过去、当前和未来的治疗模式。睡眠手术，特别是耳鼻喉科手术，在OSA临床试验的总体格局中声音较小。这些信息有助于指导未来的研究工作，并在确定研究资金优先级时指导我们的专业领域，同时鼓励广泛的跨学科研究。
NA 《喉镜》，2019年，第129卷，第1940 - 1944页
