Clinical Trials in Obstructive Sleep Apnea: Recognizing Trends and Future Opportunities

Abstract

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. Study Design Retrospective database review. Methods 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. Results 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). Conclusions 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. Level of Evidence NA Laryngoscope, 129:1940–1944, 2019

Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

“…While analyses of trends in prospective clinical trials have helped investigators in other specialties understand their respective fields, our study is the first to do so in a comprehensive manner for the field of adult spine surgery. 11,[24][25][26][27][28] Other investigations in the field of spine surgery have been more limited in scope. For example, Ohnmeiss et al analyzed 72 spine-related trials from ClinicalTrials.gov to determine their fate with regard to publication, but did not determine important aspects including trial design, randomization status, blinding, and industry influence on results.…”