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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, et al. 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;20(6):947–957.
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, et al. 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;20(6):947–957.
| Original language | English |
|---|---|
| Pages (from-to) | 947–957 |
| Number of pages | 11 |
| Journal | The Journal of Clinical Sleep Medicine |
| Volume | 20 |
| Issue number | 6 |
| Early online date | 6 Feb 2024 |
| DOIs | |
| Publication status | Published - 1 Jun 2024 |
Bibliographical note
Acknowledgement:The authors would like to thank Prof. Peter Brocklehurst (University of Birmingham), Dr Dan Cuthbertson (University of Liverpool), Prof. Jeremy Tomlinson (University of Oxford), Dr Doyo Gragn Enki (Plymouth University), and Chris Rogers (Sleep Apnoea Trust). Also, we would like to acknowledge the Birmingham Clinical Trials Unit (BCTU) for trial coordination, data management, and analysis and the Research Governance team at the University of Birmingham for governance and sponsor duties.
This project was funded as part of NIHR Clinician Scientist (CS-2013-13-029). The views presented in this manuscript are those of the authors and not those of NIHR or the NHS.
Keywords
- adherence
- continuous positive airway pressure
- Feasibility
- Obstructive sleep apnoea
- nephropathy
- neuropathy
- quality of life
- retinopathy
- type 2 diabetes
Access to Document
- MakhdomE2024Impact
This article has been accepted for publication in the Journal of Clinical Sleep Medicine published by the American Academy of Sleep Medicine; the final published version is available at https://doi.org/10.5664/jcsm.11020
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Dive into the research topics of 'The Impact of Obstructive Sleep Apnoea Treatment on Microvascular Complications in Patients with Type 2 Diabetes: A Feasibility Randomised Controlled Trial: CPAP Impact on Microvascular Complications in T2D Patients'. Together they form a unique fingerprint.Projects
- 1 Finished
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The impact of obstructive sleep apnoea treatment on microvascular complications in patients with type 2 diabetes: A feasibility study
Tahrani, A. (Principal Investigator)
1/08/16 → 31/07/20
Project: Other Government Departments