Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Apnimed
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.
Age
25–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | AD109 Dose Finding in Mild to Moderate OSA