NCT01788930

Aspirin Resistance and Sleep Apnea in Type-2 Diabetic Patients

Obstructive Sleep Apnea and Aspirin Resistance in Type-2 Diabetic Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Type-2 Diabetes and Sleep Apnea Syndrome (SAS) are both related to an increase in platelet activation. Type 2 diabetes is often associated with sleep apnea syndrome with a prevalence up to 60%. The main objective of our study is to analyze the influence of sleep apnea on the response to antiplatelet therapy in stable aspirin-treated type-2 diabetes patients. Consecutive stable aspirin-treated type-2 diabetes patients referred for suspicion of sleep apnea will be recruited after providing informed consent. Response to aspirin will be assessed with the Verify Now Aspirin(TM)rapid analyser in the morning after nocturnal polysomnography, and compared with a group of type-2 diabetes free of sleep apnea. Other endocrine, metabolic, hematologic and cardiovascular confounders will also be assessed at baseline to determine their influence on the response to aspirin. Then, Patients with severe SAS (Apnea-Hypopnea Index\> 30 events/h) and response with Aspirin (ARU \> 454) will be randomized to 3 months of active or sham continuous positive airway pressure treatment in a pilot study. After the 3-months of intervention, response to aspirin will be compared between the sham and effective CPAP groups.

Conditions

• Atherothrombosis
• Type 2 Diabetes
• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	CPAP

Timeline

• Start date: 2013-02-01
• Primary completion: 2017-07-01
• Completion: 2017-10-01
• First posted: 2013-02-11
• Last updated: 2018-10-12

Locations

1 site across 1 country: France