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Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study

NCT07744971 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

  • Sleep Quality

Interventions

DIETARY_SUPPLEMENT

Qualia Sleep Formula A

Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.

DIETARY_SUPPLEMENT

Qualia Sleep Formula B

Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.

DIETARY_SUPPLEMENT

Qualia Sleep Formula C

Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.

DIETARY_SUPPLEMENT

Qualia Sleep Formula D

Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.

Sponsors & Collaborators

  • Qualia Life Sciences

    lead INDUSTRY

Principal Investigators

  • William Director of Research · Qualia Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-28
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744971 on ClinicalTrials.gov