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.
| Original language | English |
|---|---|
| Pages (from-to) | 947-957 |
| Number of pages | 11 |
| Journal | 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
© 2024 American Academy of Sleep Medicine.Funding
The authors 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 Apnea Trust). Also, the authors acknowledge the Birmingham Clinical Trials Unit for trial coordination, data management, and analysis and the Research Governance team at the University of Birmingham for governance and sponsor duties. The manuscript has been read and approved by all named authors. This is a multicenter study that was mainly conducted at the University of Birmingham. However, participants were recruited from 13 different National Health Service Trusts throughout England (detailed in the supplemental material). This project was funded as part of National Institute for Health and Care Research (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 National Health Service. A.A.T. is currently an employee of and has shares in Novo Nordisk. The views expressed in this manuscript are those of the author and not Novo Nordisk. Novo Nordisk had no role in this manuscript. Srikanth Bellary has received speaker fees and honoraria from Novo Nordisk, Eli Lilly, Boehringer Ingelheim, and Astra Zeneca. Mayank Patel has received speaker fees from Eli Lilly and Company, Insulet, and Astra Zeneca. The other authors report no conflicts of interest.
| Funders | Funder number |
|---|---|
| University of Liverpool | |
| Plymouth University | |
| National Institute for Health and Care Research | CS-2013-13-029 |
| National Institute for Health and Care Research |
Keywords
- Neurology (clinical)
- Neurology
- Pulmonary and Respiratory Medicine
- Humans
- Middle Aged
- Male
- Treatment Outcome
- Sleep Apnea, Obstructive/therapy
- Diabetes Mellitus, Type 2/complications
- Feasibility Studies
- Female
- Aged
- Patient Compliance/statistics & numerical data
- Continuous Positive Airway Pressure/methods
- obstructive sleep apnea
- adherence
- continuous positive airway pressure
- feasibility
- type 2 diabetes
- retinopathy
- nephropathy
- neuropathy
- quality of life