The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.
Take a placebo tablet (identical in appearance to NP-2006 but containing no active ingredients) once a day, 30 to 60 minutes before bedtime for 4 weeks.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-report questionnaire that assesses sleep quality. The total score ranges from 0 to 21, where lower scores indicate better sleep quality. A decrease in the score represents an improvement in sleep health.
Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
Change from Baseline in Insomnia Severity Index (ISI) Score
The ISI is a brief instrument that assesses the severity of insomnia. The total score ranges from 0 to 28, where 0-7 indicates 'no clinically significant insomnia' and higher scores indicate more severe insomnia. A lower score represents a better outcome (improvement in insomnia symptoms).
Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
Change from Baseline in Epworth Sleepiness Scale (ESS) Score
The ESS is used to determine the level of daytime sleepiness. The total score ranges from 0 to 24. A lower score indicates less daytime sleepiness, representing a better outcome.
Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
Change from Baseline in Sleep Efficiency measured by Actigraphy
Sleep efficiency is the ratio of total sleep time to time spent in bed, measured using a wrist-worn actigraph. The value is expressed as a percentage (%). A higher percentage indicates better sleep quality.
Time frame: Baseline (Day 0), End of treatment (Day 29)
Change from Baseline in Total Sleep Time (TST) from Sleep Diary
Participants recorded their total sleep time daily in a sleep diary. The unit of measure is minutes (min). A higher value indicates an improvement in sleep duration and health.
Time frame: Baseline (Day 0), End of treatment (Day 29)
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Change from Baseline in Subjective Sleep Quality Score
Participants rated their sleep quality on a 5-point Likert scale, where 1 indicates 'Very Poor' and 5 indicates 'Very Good'. A higher score represents a better outcome (improved sleep quality).
Time frame: Baseline (Day 0), End of treatment (Day 29)
Change from Baseline in Sleep Latency measured by Polysomnography (PSG)
Sleep latency is the time it takes to fall asleep from lights-out, measured by professional PSG equipment. The unit of measure is minutes (min). A lower value indicates a better outcome (faster sleep onset).
Time frame: 0, 4, 8, 12 weeks