The Effect of NP-2006 on Sleep Quality and Health

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

Study Overview

• Status: Completed
• Conditions: Sleep Disorder (Disorder)
• Intervention / Treatment: Dietary supplement: NP-2006; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Those with severe sleep disturbances (ISI ≥ 22 points)
2. Those with severe daytime sleepiness (ESS ≥ 16 points)

3. 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
4. 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.
5. 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
6. Those receiving hormone therapy

7. 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)
8. Those who smoke excessively (> 10 cigarettes/day) or show withdrawal symptoms
9. Those who consume excessive amounts of caffeine (> 3 cups/day)
10. Those who work night shifts or have irregular bedtimes due to their job
11. 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
12. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
13. Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit
14. Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies
15. Those who have participated in a clinical trial within 1 month of the first visit
16. Those who are pregnant or lactating, or who are planning to become pregnant
17. Those who the researcher deems unsuitable for participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence A (NP-2006 first, then Placebo); 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	Dietary supplement: NP-2006; Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.; Dietary supplement: Placebo; 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.
Placebo Comparator: Sequence B (Placebo first, then NP-2006); Group that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime	Dietary supplement: NP-2006; Take a tablet containing 500 mg of NP-2006 once a day, 30 to 60 minutes before bedtime for 4 weeks.; Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	0, 4, 8, 12 weeks

Collaborators and Investigators

• Sponsor: Hanpoong Nature Pharm Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): November 10, 2024
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders
• Other Study ID Numbers: NP2006_HPN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No