The Effects on Sleep Quality of 1:4 Reishi Liquid Extract

NCT07294482 | Recruiting

• 1 other identifier: 42486
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Examining the effects of 1ml of Reishi mushroom extract (1:4 extraction ratio, two hot water extractions and an alcohol extraction), taken daily, 30 mins before bed on perceived sleep quality and stress levels. Sleep quality includes: duration, sleep onset latency, nighttime wakings, and perceived restfulness. And consequently, the potential for increased daytime energy levels and a reduction in perceived stress levels.

Conditions

Sleep

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale (Past Week Version)

  The Perceived Stress Scale (Past Week Version) is a modified version of the classic stress assessment tool that evaluates stress levels based on recent experiences within the last week. This scale helps in understanding how various situations have recently affected an individual's feelings and perceived stress levels. By focusing on a shorter time frame, it provides a more immediate assessment of stress, which can be particularly useful for quickly evaluating the effectiveness of stress management strategies or interventions. The tool retains its original structure, ensuring its reliability while making it more relevant for current stress evaluation. Score Range Minimum score: 0 Maximum score: 40 Score Interpretation Higher scores = worse outcome Higher scores indicate greater perceived stress

  Change from baseline (Day 1-5) in perceived stress levels at 4-5 weeks after the start of the intervention

• Neuro-QOL Item Bank v1.0 -Fatigue - Short Form

  This survey aims to assess the level of fatigue experienced by the participant in the past 7 days. Each question should be answered by selecting one of the five options ranging from 'Never' to 'Always'. Unabbreviated Scale Title Quality of Life in Neurological Disorders (Neuro-QoL™) Item Bank v1.0 - Fatigue - Short Form Score Range Raw score range: Most commonly used short forms: 8-40 T-score range (standardized): Typically \~30 to \~80, mean = 50, SD = 10 Score Interpretation Higher scores = worse outcome Higher scores reflect greater fatigue severity and impact

  Change from baseline (Day 1-5) in fatigue levels at 6-7 weeks after the start of the intervention

• PROMIS Sleep Disturbance Scale

  The PROMIS Sleep Disturbance Scale is a validated and widely used assessment tool developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. It is designed to measure the severity of sleep disturbances and disruptions experienced by individuals. This scale includes a range of questions that assess the frequency and impact of various sleep-related issues, such as difficulty falling asleep, nighttime awakenings, and restless sleep. Healthcare professionals and researchers rely on this scale to better understand and quantify sleep problems in patients, enabling them to tailor interventions and treatment strategies to address sleep-related concerns effectively. Unabbreviated Scale Title Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Scale Score Range Raw score range: 6-item short form: 6-30 Score Interpretation Higher scores = worse outcome Higher scores indicate greater sleep disturbance (poorer sleep

  Change from baseline (Day 1-5) in sleep disturbance levels at 6-7 weeks after the start of the intervention

Study Arms (1)

Single arm where participants act as their own control

EXPERIMENTAL

Single Arm observational where participants act as their own control

Dietary Supplement: Bristol Fungarium's 1:4 Reishi Mushroom Tincture

Interventions

Bristol Fungarium's 1:4 Reishi Mushroom Tincture DIETARY_SUPPLEMENT

UK-grown organic Reishi tincture, cloned in lab. Triple Extracted, 1: 4 Ratio via two hot water extractions and a final organic ethanol extraction to gain access to all the bioactive compounds responsible for Reishi's beneficial properties. (1g of mushrooms to every 4ml of water).

Single arm where participants act as their own control

Eligibility Criteria

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

You may qualify if:

• Can read and understand English.
• US resident.
• Willing and able to follow the requirements of the protocol.

You may not qualify if:

• Individuals with Allergies
• Pregnant or Nursing Women
• Individuals on Anticoagulants
• Immunocompromised Individuals
• Individuals with Liver Disease
• Children and Adolescents
• Individuals with Chronic Illnesses
• Those with Mental Health Disorders

Sponsors & Collaborators

• Efforia, Inc: lead

Study Sites (1)

Efforia

New York, New York, 10003, United States

RECRUITING

Related Links

• Additional information and join instructions on Efforia

Central Study Contacts

Matthew Amsden

CONTACT

646-679-2479; help@efforia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm observational where participants act as their own control

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 19, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)