Montelukast for Patients With Obstructive Sleep Apnea Syndrome

• Status: Terminated
• Trial end date: 2020-03-20
• Target enrollment: 0
• Participant gender: All

Summary

This study compares the effect of Montelukast vs Placebo on Flow Mediated Dilatation of the Brachial Artery (FMD) in patients with obstructive sleep apnea syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Act For Chronic Diseases; Direction Générale de l'Offre de Soins; Fond de dotation AGIR pour les maladies chroniques
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• With mild to moderate obstructive sleep apnea syndrome (apnea / hypopnea index> 15 and <30 events per hour)

• Little symptomatic (Epworth sleepiness score <10)

• Polysomnography within 3 months prior to inclusion

• With a history of myocardial infarction or stroke

• Affiliation to Social Security or beneficiary of such a scheme

• Signed consent

Exclusion Criteria:

• OSAS support by PPC

• Cancer

• Chronic inflammatory disease

• Asthma previously treated with Montelukast

• Chronic infectious disease

• Epworth sleepiness scale ≥10

• Contraindication to Montelukast: Hypersensitivity to the active substance or to the excipients

• Contraindications to trinitrin: hypersensitivity to nitrates, state of shock, severe hypotension, association with sildenafil, obstructive cardiomyopathy, inferior right sided myocardial infarction with right ventricular extension, acute, except in case of signs left ventricular failure, intracranial hypertension, breastfeeding

• Treatment with phenobarbital, phenytoin, rifampicin: risk of montelukast metabolism increase and thus decrease of its effectiveness

• Persons referred in Articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mothers, person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection, can not be included in clinical trials)

• Subject in exclusion period of another study

• Subject can not be contacted in case of emergency