A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea. (NCT04746105) | Clinical Trial Compass
CompletedPhase 1
A Clinical Pharmacology Study of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
Japan46 participantsStarted 2021-02-24
Plain-language summary
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Least square mean difference of Apnea hypopnea index (AHI) from placebo