Back to Search Results

The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial.

Institute of Metabolism and System Research, University of Birmingham, UK. Department of Respiratory Care, Imam Abdulrahman Bin Faisal University, SA. Centre for Endocrinology, Diabetes and Metabolism, Birmingham health partners, UK. Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK. University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK. University Hospitals of Birmingham NHS Foundation Trust, Birmingham, UK. Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK. Aston University, Birmingham, UK. University Hospitals of North Midlands NHS Trust, Stoke on Trent, UK. University Hospitals of Derby & Burton NHS Trust, Derby, UK. York Teaching Hospital NHS FT, York, UK. South Warwickshire NHS Foundation Trust, South Warwickshire, UK. University Hospital Southampton NHS FT, Southampton, UK. Royal Wolverhampton hospitals NHS Trust, Wolverhampton, UK. St George's University Hospitals NHS FT, London, UK. Calderdale and Huddersfield NHS FT, Huddersfield, UK. Bradford Teaching Hospitals NHS FT, Bradford, UK. Nottingham University Hospitals NHS Trust, Nottingham, UK. Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine. 2024
Full text from:

Other resources

Abstract

STUDY OBJECTIVES Obstructive sleep apnea (OSA) is associated with an increased risk of diabetes-related complications. Hence, it is plausible that Continuous Positive Airway Pressure (CPAP) could have a favorable impact on these complications. To assess the feasibility of conducting a randomized control trial (RCT) in patients with type 2 diabetes (T2D) and OSA over 2 years. METHODS An open-label multicenter feasibility RCT of CPAP vs no CPAP in patients with T2D and OSA. Patients with resting oxygen saturation <90%, central apnea index >15/hour or Epworth Sleepiness Scale (ESS) ≥11 were excluded. OSA was diagnosed using a multichannel portable device (ApneaLink Air, ResMed). The primary outcome measures were related to feasibility, and the secondary outcomes were changes in various clinical and biochemical parameters related to diabetes outcomes. RESULTS Eighty-three (40 CPAP vs 43 no CPAP) patients were randomized, with a median (IQR) follow-up of 645 [545, 861] days. CPAP compliance was inadequate, with a median usage of approximately 3.5 hours/night. Early CPAP use predicted longer-term compliance. The adjusted analysis showed a possible favorable association between being randomized to CPAP and several diabetes-related endpoints (chronic kidney disease (CKD), neuropathy, and quality of life (QoL)). CONCLUSIONS It was feasible to recruit, randomize, and achieve a high follow-up rate over 2 years in patients with OSA and T2D. CPAP compliance might improve by a run-in period before randomization. A full RCT is necessary to assess the observed favorable association between CPAP and CKD, neuropathy, and QoL in patients with T2D. CLINICAL TRIAL REGISTRATION Registry: ISRCTN; URL: https://www.isrctn.com/ISRCTN12361838; Title: The impact of sleep disorders in patients with type 2 diabetes; Identifier: ISRCTN12361838.