Recruitment of patients with chronic kidney disease and obstructive sleep apnoea for a clinical trial

J Sleep Res. 2021 Dec;30(6):e13384. doi: 10.1111/jsr.13384. Epub 2021 May 11.

Abstract

Obstructive sleep apnoea is common in chronic kidney disease (CKD) and may accelerate the decline in kidney function. Recruitment for a randomised controlled trial to address whether treatment of sleep apnoea with continuous positive airway pressure (CPAP) slows the progression of kidney failure may be challenging because sleep apnoea is often asymptomatic in this patient population. The present report outlines recruitment challenges and how to address them. Adult patients with CKD were recruited for a 12-month randomised, controlled, non-blinded, parallel clinical trial to evaluate the impact of CPAP therapy on kidney function. Patients completed a home sleep apnoea test and those that met pre-specified sleep apnoea and nocturnal hypoxaemia severity criteria were randomised to receive CPAP or no therapy. Although 1,665 patients were eligible to participate in the study over 3 years, only 57 (3.4%) were ultimately randomised. The sequential reasons (and number of patients) for recruitment failure were: no show at clinic appointment (137), insufficient recruiters to approach every eligible patient (461), on therapy for sleep apnoea (122), unable to provide informed consent (67), refused consent (645), home sleep apnoea test not completed (47) or inclusion criteria not met (116), and declined pre-randomisation education session (12). Many challenges limit effective recruitment, which may be addressed by hiring additional recruiters and increasing the awareness of sleep apnoea among patients with CKD. These findings can be used to improve recruitment strategies and the design of future studies.

Keywords: continuous positive airway pressure; kidney disease; recruitment; sleep apnoea.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Continuous Positive Airway Pressure
  • Humans
  • Polysomnography
  • Renal Insufficiency, Chronic* / complications
  • Renal Insufficiency, Chronic* / therapy
  • Sleep
  • Sleep Apnea, Obstructive* / complications
  • Sleep Apnea, Obstructive* / therapy