Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• Patient is male or female and is at least 18 years old and less than 65 years old

• Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome

• Patient has been using nCPAP treatment for at least 2 months prior to Visit 1

• Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments

• Patient is willing to refrain from napping for the duration of the study

Exclusion Criteria:

• Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months

• Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent

• Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1

• Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study