A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.

Phase 1

• Conditions: Obstructive sleep apnea hypopnea

• Registration Number: JPRN-jRCT2031200373
• Lead Sponsor: Mita Seiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects must meet all of the following criteria to be included in this study:

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index

Secondary Outcome Measures

Name	Time	Method
Saturation of percutaneous oxygen