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

Esraa A Makhdom; Alisha Maher; Ryan Ottridge; Mathew Nicholls; Asad Ali; Brendan G Cooper; Ramzi A Ajjan; Srikanth Bellary; Wasim Hanif; Fahmy Hanna; David Hughes; Vijay Jayagopal; Rajni Mahto; Mayank Patel; James Young; Ananth U Nayak; Mimi Z Chen; Julie Kyaw-Tun; Susana Gonzalez; Ravikanth Gouni; Anuradhaa Subramanian; Nicola Adderley; Smitaa Patel; Abd A Tahrani

doi:10.5664/jcsm.11020

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

J Clin Sleep Med. 2024 Feb 6. doi: 10.5664/jcsm.11020. Online ahead of print.

Authors

Esraa A Makhdom^{1

2

3}, Alisha Maher⁴, Ryan Ottridge⁴, Mathew Nicholls¹, Asad Ali⁵, Brendan G Cooper⁶, Ramzi A Ajjan⁷, Srikanth Bellary^{3

6

8}, Wasim Hanif³, Fahmy Hanna⁹, David Hughes¹⁰, Vijay Jayagopal¹¹, Rajni Mahto¹², Mayank Patel¹³, James Young¹⁴, Ananth U Nayak⁹, Mimi Z Chen¹⁵, Julie Kyaw-Tun¹⁶, Susana Gonzalez¹⁷, Ravikanth Gouni¹⁸, Anuradhaa Subramanian¹⁹, Nicola Adderley¹⁹, Smitaa Patel⁴, Abd A Tahrani^{1

3

6}

Affiliations

¹ Institute of Metabolism and System Research, University of Birmingham, UK.
² Department of Respiratory Care, Imam Abdulrahman Bin Faisal University, SA.
³ Centre for Endocrinology, Diabetes and Metabolism, Birmingham health partners, UK.
⁴ Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
⁵ University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
⁶ University Hospitals of Birmingham NHS Foundation Trust, Birmingham, UK.
⁷ Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
⁸ Aston University, Birmingham, UK.
⁹ University Hospitals of North Midlands NHS Trust, Stoke on Trent, UK.
¹⁰ University Hospitals of Derby & Burton NHS Trust, Derby, UK.
¹¹ York Teaching Hospital NHS FT, York, UK.
¹² South Warwickshire NHS Foundation Trust, South Warwickshire, UK.
¹³ University Hospital Southampton NHS FT, Southampton, UK.
¹⁴ Royal Wolverhampton hospitals NHS Trust, Wolverhampton, UK.
¹⁵ St George's University Hospitals NHS FT, London, UK.
¹⁶ Calderdale and Huddersfield NHS FT, Huddersfield, UK.
¹⁷ Bradford Teaching Hospitals NHS FT, Bradford, UK.
¹⁸ Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹⁹ Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

PMID: 38318821
DOI: 10.5664/jcsm.11020

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.

Keywords: adherence; continuous positive airway pressure; feasibility; nephropathy; neuropathy; obstructive sleep apnea; quality of life; retinopathy; type 2 diabetes.