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 Supplement

Part of paid clinical trials in Carlsbad, California.

Sponsor
Qualia Life Sciences
Study ID
NCT07744971
Status
Not Yet Recruiting

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Conditions

  • Sleep Quality

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Qualia Sleep Formula A — DIETARY_SUPPLEMENT
    Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
  • Qualia Sleep Formula B — DIETARY_SUPPLEMENT
    Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
  • Qualia Sleep Formula C — DIETARY_SUPPLEMENT
    Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
  • Qualia Sleep Formula D — DIETARY_SUPPLEMENT
    Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Aug 28, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Qualia Sleep Formula A
    Participants take Qualia Sleep Formula A capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
  • Experimental: Qualia Sleep Formula B
    Participants take Qualia Sleep Formula B capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
  • Experimental: Qualia Sleep Formula C
    Participants take Qualia Sleep Formula C capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
  • Experimental: Qualia Sleep Formula D
    Participants take Qualia Sleep Formula D capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.

Primary Outcome Measure

Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score [ Time Frame: Baseline to Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Qualia Life SciencesCarlsbadCalifornia92008-

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By research site
Qualia Life Sciences· Carlsbad, CA

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