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. 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	https://doi.org/10.5664/jcsm.11020
Publication status	Published - 1 Jun 2024

Bibliographical note

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

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10.5664/jcsm.11020

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

Cite this

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, 20(6), 947-957. https://doi.org/10.5664/jcsm.11020

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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. 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. ",

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",

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.}",

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day = "1",

doi = "10.5664/jcsm.11020",

language = "English",

volume = "20",

pages = "947--957",

journal = "Journal of Clinical Sleep Medicine",

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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, vol. 20, no. 6, pp. 947-957. 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 - 2024/6/1

Y1 - 2024/6/1

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. 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.

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. 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.

KW - Neurology (clinical)

KW - Neurology

KW - Pulmonary and Respiratory Medicine

KW - Humans

KW - Middle Aged

KW - Male

KW - Treatment Outcome

KW - Sleep Apnea, Obstructive/therapy

KW - Diabetes Mellitus, Type 2/complications

KW - Feasibility Studies

KW - Female

KW - Aged

KW - Patient Compliance/statistics & numerical data

KW - Continuous Positive Airway Pressure/methods

KW - obstructive sleep apnea

KW - adherence

KW - continuous positive airway pressure

KW - feasibility

KW - type 2 diabetes

KW - retinopathy

KW - nephropathy

KW - neuropathy

KW - quality of life

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

UR - http://www.scopus.com/inward/record.url?scp=85195226368&partnerID=8YFLogxK

U2 - 10.5664/jcsm.11020

DO - 10.5664/jcsm.11020

M3 - Article

C2 - 38318821

SN - 1550-9389

VL - 20

SP - 947

EP - 957

JO - Journal of Clinical Sleep Medicine

JF - Journal of Clinical Sleep Medicine

IS - 6

ER -

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

Abstract

Bibliographical note

Keywords

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