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

NCT07744971 | Not Yet Recruiting

• 1 other identifier: QLS-024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep quality; pre-sleep arousal; sleep-related daytime impairment; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score

  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.

  Baseline to Day 28

Secondary Outcomes (4)

• Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup

  Baseline to Day 28

• Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score

  Baseline to Day 28

• Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores

  Baseline to Day 28

• Safety and tolerability profile

  Days 1, 3, 7, 14, 21, and 28

Other Outcomes (1)

• Follow-Up Questionnaire (overall product experience and rating)

  5-7 days after final dose

Study Arms (4)

Qualia Sleep Formula A

EXPERIMENTAL

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

Dietary Supplement: Qualia Sleep Formula A

Qualia Sleep Formula B

EXPERIMENTAL

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

Dietary Supplement: Qualia Sleep Formula B

Qualia Sleep Formula C

EXPERIMENTAL

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

Dietary Supplement: Qualia Sleep Formula C

Qualia Sleep Formula D

EXPERIMENTAL

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

Dietary Supplement: Qualia Sleep Formula D

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 A

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 B

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 C

Qualia Sleep Formula D DIETARY_SUPPLEMENT

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

Qualia Sleep Formula D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• William Director of Research

  Qualia Life Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Director of Research

CONTACT

855-281-2328; science@qualialife.com

Abhimanyu Study coordinator

CONTACT

855-281-2328; science@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)