AD109 Dose Finding in Mild to Moderate OSA

• Status: Completed
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

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

Details

• Lead Sponsor: Apnimed

Criteria

Inclusion Criteria:

• AHI between 5 and 20 events/h

• PGI-S equal to or higher than 1, or one or more of the following symptoms:

• Snoring or nightime gasping/choking

• Daytime sleepiness, fatigue or decreased concentration

• Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache

• Irritability, decreased mood or libido

Exclusion Criteria:

• History of narcolepsy.

• Clinically significant craniofacial malformation.

• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).

• CPAP should not be used for at least 2 weeks prior to the study

• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.