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

DIETARY_SUPPLEMENT

Bristol Fungarium's 1:4 Reishi Mushroom Tincture

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).

Perceived Stress Scale (Past Week Version)

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

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

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

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

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

PROMIS Sleep Disturbance Scale

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

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

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.