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

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 GouniAnuradhaa Subramanian, Nicola Adderley, Smitaa Patel, Abd A. Tahrani

School of Biosciences

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	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

Keywords

Neurology (clinical)
Neurology
Pulmonary and Respiratory Medicine

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10.5664/jcsm.11020

https://research.birmingham.ac.uk/en/publications/the-impact-of-obstructive-sleep-apnoea-treatment-on-microvascular

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Makhdom, E. A., 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. A. (2024). The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial. Journal of Clinical Sleep Medicine. Advance online publication. https://doi.org/10.5664/jcsm.11020

@article{08e66205dfb24affa97d7c568920f409,

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

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 = "Neurology (clinical), Neurology, Pulmonary and Respiratory Medicine",

author = "Makhdom, {Esraa A.} 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 Tahrani, {Abd A.}",

year = "2024",

month = feb,

day = "6",

doi = "10.5664/jcsm.11020",

language = "English",

journal = "Journal of Clinical Sleep Medicine",

issn = "1550-9389",

publisher = "American Academy of Sleep Medicine",

}

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 2024, 'The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial', Journal of Clinical Sleep Medicine. https://doi.org/10.5664/jcsm.11020

TY - JOUR

T1 - The impact of obstructive sleep apnea treatment on microvascular complications in patients with type 2 diabetes: a feasibility randomized controlled trial

AU - Makhdom, Esraa A.

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 A.

PY - 2024/2/6

Y1 - 2024/2/6

N2 - 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

AB - 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

KW - Neurology (clinical)

KW - Neurology

KW - Pulmonary and Respiratory Medicine

UR - https://jcsm.aasm.org/doi/10.5664/jcsm.11020

U2 - 10.5664/jcsm.11020

DO - 10.5664/jcsm.11020

M3 - Article

SN - 1550-9389

JO - Journal of Clinical Sleep Medicine

JF - Journal of Clinical Sleep Medicine

ER -

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

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Keywords

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