The Impact of Obstructive Sleep Apnea Treatment on Microvascular Complications in Patients with Type 2 Diabetes: a Feasibility Randomized Controlled Trial

Overview

Journal J Clin Sleep Med

Specialties Neurology
Psychiatry

Date 2024 Feb 6

PMID 38318821

Authors

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

Affiliations

Soon will be listed here.

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. . 2024;20(6):947-957.

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