The Effect of NP-2006 on Sleep Quality and Health

NCT07485959 | Completed

• 1 other identifier: NP2006_HPN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change from Baseline in Sleep Efficiency measured by Actigraphy

  Baseline (Day 0), End of treatment (Day 29)

• Change from Baseline in Total Sleep Time (TST) from Sleep Diary

  Baseline (Day 0), End of treatment (Day 29)

• Change from Baseline in Subjective Sleep Quality Score

  Baseline (Day 0), End of treatment (Day 29)

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

  0, 4, 8, 12 weeks

Study Arms (2)

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

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

Dietary Supplement: NP-2006; Dietary Supplement: Placebo

Interventions

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.

Sequence A (NP-2006 first, then Placebo); Sequence B (Placebo first, then NP-2006)

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.

Sequence A (NP-2006 first, then Placebo); Sequence B (Placebo first, then NP-2006)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanpoong Nature Pharm Co., Ltd.: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: May 12, 2023
• Primary Completion: November 10, 2024
• Study Completion: August 13, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

KR (1)