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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (4)

• Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup [Срок оценки: Baseline to Day 28]
• Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score [Срок оценки: Baseline to Day 28]
• Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores [Срок оценки: Baseline to Day 28]
• Safety and tolerability profile [Срок оценки: Days 1, 3, 7, 14, 21, and 28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Qualia Life Sciences — Carlsbad

Идентификаторы

NCT: NCT07744971 · QLS-024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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