Sleep Disorder (Disorder)NCT07485959
The Effect of NP-2006 on Sleep Quality and Health
A study testing NP-2006 in people with Sleep Disorder (Disorder), run by Hanpoong Nature Pharm Co., Ltd. at 1 site in South Korea.
Trial summary
The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- NP-2006
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2023to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Effect of NP-2006 on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia
The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- NP-2006, Placebo
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-2006Dietary supplement
Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (NP-2006 first, then Placebo) | Experimental | Group that took tablets containing 500mg of NP-2006 (NP-2006, crystalline cellulose, tapioca starch, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before going to sleep Receives: Dietary Supplement: NP-2006; Dietary Supplement: Placebo |
| Sequence B (Placebo first, then NP-2006) | Placebo comparator | Group that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime Receives: Dietary Supplement: NP-2006; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline (Day 0), End of treatment (Day 29)
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).
Measured: 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).
Measured: 0, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start12 May 2023
- Primary completion10 Nov 2024
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanpoong Nature Pharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485959
- Sponsor's protocol ID
- NP2006_HPN
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NP-2006 on Sleep Efficiency and Quality in Healthy Volunteers With Persistent Subclinical Insomnia
- ClinicalTrials.gov ID
- NCT07485959
- Acronym / sponsor ID
- NP2006_HPN
- Conditions
- Sleep Disorder (Disorder)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hanpoong Nature Pharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (NP-2006 first, then Placebo) | Experimental | Dietary Supplement: NP-2006, Dietary Supplement: PlaceboGroup that took tablets containing 500mg of NP-2006 (NP-2006, crystalline cellulose, tapioca starch, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before going to sleep |
| Sequence B (Placebo first, then NP-2006) | Placebo comparator | Dietary Supplement: NP-2006, Dietary Supplement: PlaceboGroup that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP-2006Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks. | Dietary supplement | Sequence A (NP-2006 first, then Placebo), Sequence B (Placebo first, then NP-2006) |
| PlaceboTake 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. | Dietary supplement | Sequence A (NP-2006 first, then Placebo), Sequence B (Placebo first, then NP-2006) |
Primary outcome
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.
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).
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.
4 secondary outcomes
Change from Baseline in Sleep Efficiency measured by Actigraphy
Time frame: Baseline (Day 0), End of treatment (Day 29)
Change from Baseline in Total Sleep Time (TST) from Sleep Diary
Time frame: Baseline (Day 0), End of treatment (Day 29)
Change from Baseline in Subjective Sleep Quality Score
Time frame: Baseline (Day 0), End of treatment (Day 29)
Change from Baseline in Sleep Latency measured by Polysomnography (PSG)
Time frame: 0, 4, 8, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NP-2006 in people with Sleep Disorder (Disorder), run by Hanpoong Nature Pharm Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score (time frame: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.