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
; 20(6): 947-957, 2024 Jun 01.
Article
in En
| MEDLINE
| ID: mdl-38318821
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Feasibility Studies
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Sleep Apnea, Obstructive
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Continuous Positive Airway Pressure
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Diabetes Mellitus, Type 2
Type of study:
Clinical_trials
/
Prognostic_studies
Limits:
Aged
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Female
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Humans
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Male
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Middle aged
Language:
En
Journal:
J Clin Sleep Med
/
J. clin. sleep med
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Journal of clinical sleep medicine
Year:
2024
Type:
Article
Affiliation country:
United kingdom