The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes : a feasibility randomized controlled trial.
Makhdom, Esraa A. Maher, Alisha Ottridge, Ryan Nicholls, Mathew Ali, Asad Cooper, Brendan Ajjan, Ramzi A. Bellary, Srikanth Hanif, Wasim Hanna, Fahmy
Makhdom, Esraa A.
Maher, Alisha
Ottridge, Ryan
Nicholls, Mathew
Ali, Asad
Cooper, Brendan
Ajjan, Ramzi A.
Bellary, Srikanth
Hanif, Wasim
Hanna, Fahmy
Affiliation
University of Birmingham; Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia; Birmingham Health Partners; University Hospitals Coventry and Warwickshire NHS Trust; University Hospitals of Birmingham NHS Foundation Trust; South Warwickshire University NHS Foundation Trust; et al.
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Publication date
2024-06-01
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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. We assessed the feasibility of conducting a randomized control trial in patients with type 2 diabetes and OSA over 2 years.
Methods: We conducted an open-label multicenter feasibility randomized control trial of CPAP vs no CPAP in patients with type 2 diabetes and OSA. Patients with resting oxygen saturation < 90%, central apnea index > 15 events/h, or Epworth Sleepiness Scale ≥ 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 randomly assigned, with a median (interquartile range) 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 randomly assigned to CPAP and several diabetes-related end points (chronic kidney disease, neuropathy, and quality of life).
Conclusions: It was feasible to recruit, randomly assign, and achieve a high follow-up rate over 2 years in patients with OSA and type 2 diabetes. CPAP compliance might improve by a run-in period before randomization. A full randomized control trial is necessary to assess the observed favorable association between CPAP and chronic kidney disease , neuropathy, and quality of life in patients with type 2 diabetes.
Clinical trial registration: Registry: ISRCTN; Name: The impact of sleep disorders in patients with type 2 diabetes; URL: https://www.isrctn.com/ISRCTN12361838; Identifier: ISRCTN12361838.
Citation
Makhdom EA, Maher A, Ottridge R, Nicholls M, Ali A, Cooper BG, Ajjan RA, Bellary S, Hanif W, Hanna F, Hughes D, Jayagopal V, Mahto R, Patel M, Young J, Nayak AU, Chen MZ, Kyaw-Tun J, Gonzalez S, Gouni R, Subramanian A, Adderley N, Patel S, Tahrani AA. 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 Jun 1;20(6):947-957. doi: 10.5664/jcsm.11020.
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Article