A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea

Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea

This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.

Inclusion Criteria:

• OSA diagnosis; OSA severity AHI: 15-30
• Population aged 20-65
• Gender: Males and Females
• BMI < 30
• OSA patients that cannot tolerate CPAP
• OSA patients who use CPAP will not use the device during the entire duration of the study

Exclusion Criteria:

• Minors
• Severity of OSA outside the determined boundaries
• Pregnancy
• BMI > 30
• Medical history of narcotic dependency