Perspectives of African American couples regarding participation in trials of treatments for obstructive sleep apnea.

RATIONALE: Continuous positive airway pressure (CPAP) improves excessive daytime sleepiness, but there is insufficient evidence that CPAP prevents long-term clinically important adverse outcomes such as cardiovascular events and cognitive functioning particularly among diverse populations. This lack of evidence is particularly concerning for African American patients who face disproportionate barriers to care.

GOALS: To determine the perceptions of African American patients with OSA and their bed partners regarding participating in clinical trials evaluating the effects of CPAP on long-term outcomes.

METHODS

We interviewed African American patients of an urban safety-net health care system with OSA who were prescribed CPAP and their bed partners. Recruitment continued until theoretical saturation was achieved. Transcripts were analyzed using the principles of thematic analysis.

RESULTS

We interviewed 18 OSA patients and 18 bed partners. We identified six themes pertaining to patients' and bed partners' perspectives of the benefits and risks to participation in clinical trials about CPAP effectiveness, and characteristics of optimal trial design. Participants described learning the true efficacy of CPAP as essentially the only benefit of participation, while emphasizing the jeopardization of health and navigating mistrust and deception as costs of participation. Participants encouraged the integration of patient voices, the participation of diverse investigators, the involvement of bed partners, and the incorporation of patient education on CPAP adherence in designing optimal clinical trials.

CONCLUSIONS

African American patients with OSA and their bed partners expressed several concerns regarding participation in clinical trials and offered suggestions for improving the design of clinical trials in this population.