Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
10 de agosto de 2026 actualizado por: Qualia Life Sciences
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: William Director of Research
- Número de teléfono: 855-281-2328
- Correo electrónico: science@qualialife.com
Copia de seguridad de contactos de estudio
- Nombre: Abhimanyu Study coordinator
- Número de teléfono: 855-281-2328
- Correo electrónico: science@qualialife.com
Ubicaciones de estudio
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California
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Carlsbad, California, Estados Unidos, 92008
- Qualia Life Sciences
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Qualia Sleep Formula A
Participants take Qualia Sleep Formula A capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
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Oral Capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
Experimental: Qualia Sleep Formula B
Participants take Qualia Sleep Formula B capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
Experimental: Qualia Sleep Formula C
Participants take Qualia Sleep Formula C capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
Experimental: Qualia Sleep Formula D
Participants take Qualia Sleep Formula D capsules, 2 capsules once daily at night 30-60 minutes before bed, for 28 consecutive days.
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Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
Periodo de tiempo: 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.
|
Baseline to Day 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
Periodo de tiempo: Baseline to Day 28
|
Change in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance.
|
Baseline to Day 28
|
|
Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score
Periodo de tiempo: 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.
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Baseline to Day 28
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Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores
Periodo de tiempo: 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.
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Baseline to Day 28
|
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Safety and tolerability profile
Periodo de tiempo: Days 1, 3, 7, 14, 21, and 28
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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.
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Days 1, 3, 7, 14, 21, and 28
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Follow-Up Questionnaire (overall product experience and rating)
Periodo de tiempo: 5-7 days after final dose
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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.
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5-7 days after final dose
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: William Director of Research, Qualia Life Sciences
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
28 de agosto de 2026
Finalización primaria (Estimado)
31 de octubre de 2026
Finalización del estudio (Estimado)
31 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
29 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de julio de 2026
Publicado por primera vez (Actual)
4 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QLS-024
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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