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Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
Condition(s) studied
Sleep Quality
Investigational drug(s) / intervention(s)
Qualia Sleep Formula AQualia Sleep Formula BQualia Sleep Formula CQualia Sleep Formula D
Qualia Sleep Formula A: Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Qualia Sleep Formula B: Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Qualia Sleep Formula C: Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Qualia Sleep Formula D: Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Study summary
This is a randomized, open-label, 4-arm pilot study designed to evaluate the efficacy and tolerability of four Qualia Sleep formulations (Formulas A, B, C, and D) in healthy adults aged 18 years and older who report poor sleep quality. The investigational products are encapsulated dietary supplements intended to support sleep quality and satisfaction. Approximately 100 participants will be allocated to one of four arms (n≈25 per arm) and will take 2 capsules of their assigned Qualia Sleep formula once daily for 28 consecutive days, administered 30-60 minutes before bedtime. The primary objective is to assess changes in sleep quality and satisfaction from baseline to Day 28 using the PROMIS Sleep Disturbance - Short Form 8b, with secondary outcomes including sleep-related impairment, pre-sleep arousal, and overall safety and tolerability. All study data, including self-reported sleep and safety questionnaires, will be collected electronically via secure links; there are no in-person visits or clinic-based assessments.
Eligibility
Inclusion criteria:
* Healthy female and male adults aged 18 years and older with poor sleep quality.
* A raw score ≥25 on the PROMIS Sleep Disturbance - Short Form questionnaire (preference given to participants with a higher score).
* Can read and write English.
* Provide voluntary, written, informed consent to participate in the study.
* Agree to provide a valid cell phone number and are willing to receive communications through text.
* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly.
* Willing to complete questionnaires, records, and diaries associated with the study.
Exclusion criteria:
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
* Known food intolerances/allergy to any ingredients in the product.
* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer.
* Having had a significant cardiovascular event in the past 6 months.
* Taking any of the following medications, or on immunosuppressive therapy:
* Psychiatric or neurological medications - including antidepressants (e.g., MAO inhibitors, SSRIs) and anxiolytics
* Sleep medications - sedatives, hypnotics, benzodiazepines, dual orexin receptor antagonists, melatonin receptor agonists
* Individuals who were deemed incompatible with the test protocol.
* Adults lacking capacity to consent.
* Unable to read and understand English.
Primary outcome measure(s)
- Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score — Baseline to Day 28
Change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation. The 8-item questionnaire assesses self-reported perceptions of sleep quality, sleep depth and restoration, and difficulties and dissatisfaction with sleep during the past 7 days. Total raw score ranges from 8 to 40, with higher scores indicating greater sleep disturbance.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Qualia Life Sciences |
Carlsbad |
California |
|
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