Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07744971 on ClinicalTrials.gov ↗ ← All trials in the USA