Qualia Night Pilot Study

Qualia Night Pilot Study

Qualia Night - Pilot Study

STUDY BACKGROUND

Qualia Night was designed to support the body’s natural shift from daytime function, a period characterized by activity, into the rest, repair, and rejuvenation functions that dominate the night. One of the goals of the product is to promote a feeling of calmness and relaxation in the evening. Another goal is to support sounder sleep. A third goal is to have users wake feeling refreshed and restored. And the last goal is for users to have a next-day nootropic experience, with what they took at night supporting performance in areas such as productivity, energy, and stress the following day.*

STUDY Overview

A randomized double-blind placebo-controlled crossover study on otherwise healthy adults with poor sleep quality (i.e., occasional sleeplessness) was conducted to examine Qualia Night supplementation on sleep quality and health outcomes. The outcomes measured were sleep quality, restorative sleep, health-related quality of life, perceived stress, mood, daytime fatigue, cognitive function, and product usability/likability.

METHODS

50 Participants who met the inclusion criteria (based on responses to the Prescreen Survey) were contacted to discuss the intervention. Interested participants signed an Institutional Review Board Approved Informed Consent (Sterling IRB) and then Qualia Night and placebo were delivered to their home address. 

50 Participants were instructed to take four capsules 3 to 4 hours prior to nighttime sleep for 5 days each week (self-selected days). Each evening at 6:00 pm a text reminder was sent to all participants to take the capsules 3 to 4 hours before bed. Each morning the participants were sent a Daily Diary to complete that assessed their supplement adherence, adverse events, sleep quality, and mood. As well, the participants completed assessments of their sleep quality, productivity, executive functioning (i.e., cognition), perceived stress, mood, daytime fatigue, and health-related quality of life at Baseline, following talking Qualia Night, and following taking a placebo.

A total of 25 adults provided informed consent and were enrolled in the study. All 25 participants completed the study, representing an adherence rate of 100%.

RESULTS

The Qualia Night group showed an improvement vs. baseline in all areas assessed.  Improvements, as compared with placebo, were shown in restorative sleep, productivity, vigor, perceived stress, and self-assessed general health, although the improvements vs. placebo were not statistically significant (p>0.05). The participants showed the largest percent improvement vs. baseline in the areas of sleep quality, stress reduction, productivity, energy levels, and general mental health related quality of life measures.* These differences were statistically significant (p<0.05).

While Neurohacker Collective is encouraged by the results of this study, additional studies are required to more definitively document the benefits of supplementation with Qualia Night. 

MEASURES 

Main Outcome Measures: The following measures were completed at Baseline, following supplementation with Qualia Night, and following supplementation with a placebo.

  • Insomnia Severity Index:  The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. A higher score indicates more insomnia severity. The total score is interpreted as follows: absence of insomnia (0–7); sub-threshold insomnia (8–14); moderate insomnia (15–21); and severe insomnia (22–28).

  • Pittsburgh Sleep Quality Index (PSQI): The PSQI is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates “poor” from “good” sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

  • Restorative Sleep Questionnaire: The Restorative Sleep Questionnaire measures refreshing quality of sleep. Nonrestorative sleep (NRS) is one of the cardinal symptoms of insomnia and can occur independent of other components of insomnia. It has 9 items with answers scaled from 1 to 5. Some items are reversed scored. The total score is an average score based on all 9 items. This has good psychometric properties (Drake et al., 2014). 

  • Profile of Mood States (POMS): The POMS assesses the common mood states of tension, anger, vigor, fatigue, depression, esteem, and confusion. The POMS is not a diagnostic tool but rather measures mood states commonly experienced by healthy people. A composite score, the total mood disturbance score, is computed by summing each of the individual scores for tension, depression, anxiety, fatigue, and confusion, with vigor scores subtracted to indicate patients' total mood. Each item of the POMS short form is scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). This scale has good to excellent reliability and validity (McNair et al., educational and Industrial Testing Service, San Diego, CA1992.

  • Flinders Fatigue Scale: The Flinders Fatigue Scale is a 7-item scale that measures various characteristics of daytime fatigue (e.g., frequency, severity) experienced over the past 2 weeks. The items tap into commonly reported themes of how problematic fatigue is, the consequences of fatigue, frequency, severity, and perception of fatigue's association with sleep. Six items are presented in Likert format, with responses ranging from 0 (not at all) to 4 (extremely). Item 5 measures the time of day when fatigue is experienced and uses a multiple-item checklist. Respondents can indicate more than one response for item 5, and it is scored as the sum of all times of the day indicated by the respondent. One item explicitly asks for respondents' impression of whether they attribute their fatigue to their sleep. Total fatigue is calculated as the sum of all individual items. Total fatigue scores range from 0 to 31, with higher scores indicating greater fatigue. A clear description of the term “fatigue” is provided in the initial instructions to the scale of: “We are interested in the extent that you have felt fatigued (tired, weary, exhausted) over the last two weeks. We do not mean feelings of sleepiness (the likelihood of falling asleep)” (Gradisar et al., 2007). 

  • Perceived Stress Scale: The shortened version of Perceived Stress Scale (4-items) measures the degree to which situations are appraised as stressful. That is, “how unpredictable, uncontrollable, and overloaded respondents find their lives” during the two weeks. The four items are: (1) “How often have you felt that you were unable to control the important things in your life?, (2) How often have you felt confident about your ability to handle your personal problems?, (3) How often have you felt that things were going your way?, and (4) How often have you felt difficulties were piling up so high that you could not overcome them”. This scale has excellent psychometric properties (Cohen et al., 1983).

  • Health-related Quality of Life: The CDC Health-related Quality of Life measure was used to assess health-related quality of life (e.g., mental and physical health, sleep quality, pain level; Andresen et al., 2001). This scale has excellent psychometric properties (Zack et al., 2014). 

  • Adult Executive Functioning Inventory (ADEXI): The ADEXI is a 14‐item questionnaire measuring cognitive abilities of working memory and inhibition. This scale has good psychometric properties with adults (Holst & Thorell, 2018).

  • Daily Diary: The participants also completed a brief daily diary regarding their sleep quality, immune health, productivity, mood, adherence, and adverse events.


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