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

Starting soon · Not applicable

Conditions studied: Sleep Quality

In brief

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 facts

Study ID: NCT07744971
Run by: Qualia Life Sciences
People needed: 100
Starts: 2026-08-28
Expected to finish: 2026-10-31
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Qualia Life Sciences — Carlsbad, California, United States

Full record on ClinicalTrials.gov

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