Skip to main content
OpenTrials
Completed

NCT Number: NCT07485959

The Effect of NP-2006 on Sleep Quality and Health

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disorder (Disorder) Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • Those with severe sleep disturbances (ISI ≥ 22 points)
  • Those with severe daytime sleepiness (ESS ≥ 16 points)
  • Those with the following conditions:
  • Snoring, sleep apnea, restless legs syndrome, periodic limb movement disorder (PLMD), depression, narcolepsy, or respiratory disease that cause sleep disturbances
  • Itching, nocturia, chronic pain, or muscle cramps that affect sleep
  • Uncontrolled diabetes or hypertension
  • 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
  • Men > 210 g/week (approximately 4 bottles of soju/week, approximately 4 glasses/day)
  • Women > 140 g/week (approximately 2.5 bottles of soju/week, approximately 2.5 glasses/day)
  • Those who smoke excessively (> 10 cigarettes/day) or show withdrawal symptoms
  • Those who consume excessive amounts of caffeine (> 3 cups/day)
  • Those who work night shifts or have irregular bedtimes due to their job
  • Those who have traveled or plan to travel long distances to a country with a different time zone within 1 month of the first visit
  • Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
  • Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit
  • Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies
  • Those who have participated in a clinical trial within 1 month of the first visit
  • Those who are pregnant or lactating, or who are planning to become pregnant
  • Those who the researcher deems unsuitable for participation in this study

Treatment and study plan

NP-2006

Dietary Supplement

Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.

Placebo

Dietary Supplement

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.

Primary outcomes

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

    Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

    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.

  2. Change from Baseline in Insomnia Severity Index (ISI) Score

    Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

    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).

  3. Change from Baseline in Epworth Sleepiness Scale (ESS) Score

    Time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

    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.

Secondary outcomes

  1. Change from Baseline in Sleep Efficiency measured by Actigraphy

    Time frame: Baseline (Day 0), End of treatment (Day 29)

    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.

  2. Change from Baseline in Total Sleep Time (TST) from Sleep Diary

    Time frame: Baseline (Day 0), End of treatment (Day 29)

    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.

  3. Change from Baseline in Subjective Sleep Quality Score

    Time frame: Baseline (Day 0), End of treatment (Day 29)

    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).

  4. Change from Baseline in Sleep Latency measured by Polysomnography (PSG)

    Time frame: 0, 4, 8, 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

Hanpoong Nature Pharm Co., Ltd.

Industry

Registry information

Official study title

Effect of NP-2006 on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 20, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.