Rationale and design of the Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) trial

Abstract

The Hyperglycemic Profiles in Obstructive Sleep Apnea (HYPNOS) randomized clinical trial was conducted in adults with type 2 diabetes and moderate-to-severe obstructive sleep apnea (OSA) to determine whether treatment with positive airway pressure (PAP) therapy is associated with improvements in glycemic measures. Participants were randomly assigned to PAP therapy with lifestyle counseling or lifestyle counseling alone. While observational and experimental evidence indicate that intermittent hypoxemia and recurrent arousals in OSA may alter glucose metabolism and worsen glycemic measures, the effect of treating OSA with PAP therapy on these measures in type 2 diabetes is uncertain. Adequately powered randomized clinical trials have yet to be performed to demonstrate whether PAP therapy for OSA in patients with type 2 diabetes can improve glycemic measures. The HYPNOS trial was designed to determine whether PAP therapy for OSA in patients with type 2 diabetes over 3 months leads to improvements in glycemic measures including glycemic variability (standard deviation) based on Dexcom G4 Platinum continuous glucose monitoring. Secondary objectives were to assess the effects of PAP therapy for OSA on measures of: (1) glycemic variability based on Abbott Freestyle Pro Libre continuous glucose monitoring; (2) point-of-care hemoglobin A1c (HbA1c); (3) degree of post-prandial hyperglycemia as determined by 7-point self-monitoring of blood glucose; (4) clinic and ambulatory blood pressure; and (5) endothelial function. The HYPNOS trial was designed to address gaps in our understanding of the effects of PAP therapy on glucose metabolism in adults with type 2 diabetes and moderate-to-severe OSA.Trial Registration: ClinicalTrials.gov Identifier NCT02454153