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

Esraa 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 Tahrani

doi:10.5664/jcsm.11020

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

Esraa 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 GouniAnuradhaa Subramanian, Nicola Adderley, Smitaa Patel, Abd Tahrani

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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

Original language	English
Journal	The Journal of Clinical Sleep Medicine
Early online date	6 Feb 2024
DOIs	https://doi.org/10.5664/jcsm.11020
Publication status	E-pub ahead of print - 6 Feb 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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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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.
NIHR
1/08/16 → 31/07/20
Project: Other Government Departments

Cite this

Makhdom, E., Maher, A., Ottridge, R., Nicholls, M., Ali, A., Cooper, B. G., Ajjan, R. A., Bellary, S., Hanif, W., Hanna, F., Hughes, D., Jayagopal, V., Mahto, R., Patel, M., Young, J., Nayak, A. U., Chen, M. Z., Kyaw-Tun, J., Gonzalez, S., ... Tahrani, A. (2024). 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. The Journal of Clinical Sleep Medicine. Advance online publication. https://doi.org/10.5664/jcsm.11020

@article{2c61cee78b1a4790904cdaf3ca2aaf22,

title = "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",

abstract = "AbstractSTUDY 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, Obstructive sleep apnoea, nephropathy, neuropathy, quality of life, retinopathy, type 2 diabetes",

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

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.",

year = "2024",

month = feb,

day = "6",

doi = "10.5664/jcsm.11020",

language = "English",

journal = "The Journal of Clinical Sleep Medicine",

issn = "1550-9389",

publisher = "American Academy of Sleep Medicine",

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Makhdom, E, 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, A 2024, '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', The Journal of Clinical Sleep Medicine. https://doi.org/10.5664/jcsm.11020

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. / Makhdom, Esraa; Maher, Alisha; Ottridge, Ryan et al.
In: The Journal of Clinical Sleep Medicine, 06.02.2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The Impact of Obstructive Sleep Apnoea Treatment on Microvascular Complications in Patients with Type 2 Diabetes: A Feasibility Randomised Controlled Trial

T2 - CPAP Impact on Microvascular Complications in T2D Patients

AU - Makhdom, Esraa

AU - Maher, Alisha

AU - Ottridge, Ryan

AU - Nicholls, Mathew

AU - Ali, Asad

AU - Cooper, Brendan G

AU - Ajjan, Ramzi A

AU - Bellary, Srikanth

AU - Hanif, Wasim

AU - Hanna, Fahmy

AU - Hughes, David

AU - Jayagopal, Vijay

AU - Mahto, Rajni

AU - Patel, Mayank

AU - Young, James

AU - Nayak, Ananth U

AU - Chen, Mimi Z

AU - Kyaw-Tun, Julie

AU - Gonzalez, Susana

AU - Gouni, Ravikanth

AU - Subramanian, Anuradhaa

AU - Adderley, Nicola

AU - Patel, Smitaa

AU - Tahrani, Abd

N1 - 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.

PY - 2024/2/6

Y1 - 2024/2/6

N2 - AbstractSTUDY 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

AB - AbstractSTUDY 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

KW - adherence

KW - continuous positive airway pressure

KW - Feasibility

KW - Obstructive sleep apnoea

KW - nephropathy

KW - neuropathy

KW - quality of life

KW - retinopathy

KW - type 2 diabetes

UR - https://jcsm.aasm.org/journal/jcsm

U2 - 10.5664/jcsm.11020

DO - 10.5664/jcsm.11020

M3 - Article

SN - 1550-9389

JO - The Journal of Clinical Sleep Medicine

JF - The Journal of Clinical Sleep Medicine

ER -

Makhdom E, Maher A, Ottridge R, Nicholls M, Ali A, Cooper BG et al. 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. The Journal of Clinical Sleep Medicine. 2024 Feb 6. Epub 2024 Feb 6. doi: 10.5664/jcsm.11020

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

Abstract

Bibliographical note

Keywords

UN SDGs

Access to Document

Embargoed Document

Fingerprint

Projects

The impact of obstructive sleep apnoea treatment on microvascular complications in patients with type 2 diabetes: A feasibility study

Cite this