Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
Qualia Life Sciences
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.
Description
The primary aim of this open-label, four-arm pilot study is to evaluate the efficacy of four Qualia Sleep formulations (A, B, C, and D) in improving sleep quality and satisfaction over 28 days in adults reporting sleep disturbances, as assessed by the PROMIS Sleep Disturbance - Short Form 8b (PROMIS-SD). The primary objective is to determine the change from baseline to day 28 in PROMIS-SD scores across all participants using each formulation. Secondary objectives are to: (1) assess changes in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance; (2) evaluate changes in sleep…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 compl…
Interventions
- Dietary SupplementQualia Sleep Formula A
Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
- Dietary SupplementQualia Sleep Formula B
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
- Dietary SupplementQualia Sleep Formula C
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
- Dietary SupplementQualia Sleep Formula D
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Location
- Qualia Life SciencesCarlsbad, California