Qualia Life Sciences
Carlsbad, California, 92008, United States
NCT Number: NCT07744971
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Carlsbad, California, 92008, United States
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-related daytime impairment using the PROMIS Sleep-Related Impairment Short Form 8a (PROMIS-SRI) in both the overall sample and the higher-disturbance subgroup; (3) examine changes in somatic and cognitive pre-sleep arousal as measured by the Pre-Sleep Arousal Scale (PSAS) in both the overall sample and the higher-disturbance subgroup; and (4) characterize the safety and tolerability profile of each formulation over the 28-day supplementation period. Participants take 2 capsules once daily at night, 30-60 minutes before bed, for 28 consecutive days. Participants complete regular check-in surveys on days 1, 3, 7, 14, 21, and 28. All study data will be collected electronically using secure survey links completed remotely on participants' own devices.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Time frame: Baseline to Day 28
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.
Time frame: Baseline to Day 28
Change in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance.
Time frame: Baseline to Day 28
Changes in sleep-related daytime impairment using the PROMIS-SRI in both the overall sample and the higher-disturbance subgroup. The 8-item questionnaire assesses daytime consequences of poor sleep. Total raw score ranges from 8 to 40, with higher scores indicating greater sleep-related impairment.
Time frame: Baseline to Day 28
Changes in somatic and cognitive pre-sleep arousal as measured by the PSAS in both the overall sample and the higher-disturbance subgroup. Two subscales (somatic items 1-8, cognitive items 9-16), each scoring 8-40, with higher scores indicating greater pre-sleep arousal.
Time frame: Days 1, 3, 7, 14, 21, and 28
Characterize the safety and tolerability profile of each formulation over the 28-day supplementation period using the Safety and Tolerability Questionnaire assessing symptoms including increased anxiety/worry, headache, mood changes, stomach upset/nausea, dizziness, bloating, itching, and sexual dysfunction. Higher score = worsening of symptoms.
Time frame: 5-7 days after final dose
Overall experience of the product, product rating, and purchase interest. Success criteria for the test product is at least 80% excellent + good ratings on the overall experience question, with more than 25% of all ratings being excellent.
Contact information is provided by the study sponsor or research team.
Abhimanyu Study coordinator
CONTACT
William Director of Research
CONTACT
Qualia Life Sciences
Industry
Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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