Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04746105
Eligibility Criteria:
Inclusion Criteria:
* Japanese male and female, age 20 years or older at the time of informed consent
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder
* Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea
* Patients with percutaneous arterial oxygen saturation (SpO2) \<94% by pulse oximetry at visit 1
* Other protocol defined exclusion criteria could apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04746105
Study Brief:
Protocol Section:
NCT04746105