CompletedNot Applicable

The Effect of NP-2006 on Sleep Quality and Health

South Korea48 participantsStarted 2023-05-12

Plain-language summary

The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia

Age range19 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Those who agreed to participate in this study and signed a written consent form
✓. Adults aged 19 to 65 years, male or female
✓. Those with poor sleep quality (PSQI score \> 5 points)

✕. Those with severe sleep disturbances (ISI ≥ 22 points)
✕. Those with severe daytime sleepiness (ESS ≥ 16 points)
✕. Those with the following conditions:
✕. Those experiencing changes that could cause excessive stress within 2 weeks of the first visit: death of a spouse, family discord, lawsuits/disputes, sudden financial difficulties, immigration, etc.
✕. Those taking medications (corticosteroids, psychotropic medications, etc.) that could affect sleep within 1 month of the first visit or expected to take them during the study participation
✕. Those receiving hormone therapy
✕. Those who regularly consume excessive alcohol
✕. Those who smoke excessively (\> 10 cigarettes/day) or show withdrawal symptoms

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Change from Baseline in Insomnia Severity Index (ISI) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Change from Baseline in Epworth Sleepiness Scale (ESS) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

NCT IDNCT07485959

SponsorHanpoong Nature Pharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-10

Who can participate

Age range19 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Those who agreed to participate in this study and signed a written consent form
✓. Adults aged 19 to 65 years, male or female
✓. Those with poor sleep quality (PSQI score \> 5 points)

✕. Those with severe sleep disturbances (ISI ≥ 22 points)
✕. Those with severe daytime sleepiness (ESS ≥ 16 points)
✕. Those with the following conditions:
✕. Those experiencing changes that could cause excessive stress within 2 weeks of the first visit: death of a spouse, family discord, lawsuits/disputes, sudden financial difficulties, immigration, etc.
✕. Those taking medications (corticosteroids, psychotropic medications, etc.) that could affect sleep within 1 month of the first visit or expected to take them during the study participation
✕. Those receiving hormone therapy
✕. Those who regularly consume excessive alcohol
✕. Those who smoke excessively (\> 10 cigarettes/day) or show withdrawal symptoms

What they're measuring

Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Change from Baseline in Insomnia Severity Index (ISI) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Change from Baseline in Epworth Sleepiness Scale (ESS) Score

Timeframe: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks