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.

Participants underwent initial pre-screening to determine potential study eligibility. Participants selected for further screening had either a previous history of OSA of a severity consistent with enrollment criteria or were at high risk (e.g. as assessed by STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG) enrollment criteria at Visit 1 were eligible for a screening PSG.

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.

Adverse Events were collected for each subject for up to 12 weeks. The overall study duration was up to 12 weeks (Screening period, up to 4 weeks; 3-period crossover, up to 6 weeks; End of Study Evaluation, 2 weeks post crossover period).

The definition of adverse events is the same as clinicaltrials.gov. All AE and SAE were collected from the signing of the informed consent form (ICF) until the end of the study at the timepoints specified in the schedule of assessments