A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Subjects received single-dose of 10 mg of TS-142 (oral tablet)
Subjects received single-dose matched placebo to TS-142 (oral tablet)
Taisho Pharmaceutical Co., Ltd selected site
Tokyo, Japan
Least square mean difference of Apnea hypopnea index (AHI) from placebo
AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).
Time frame: Day 1
Least square mean difference of the mean SpO2 in total sleep time from placebo
The SpO2 will be simultaneously measured with PSG. The mean SpO2 during sleep determined by PSG will be calculated.
Time frame: Day 1
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