Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
10 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
100
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: William Director of Research
- Numero di telefono: 855-281-2328
- Email: science@qualialife.com
Backup dei contatti dello studio
- Nome: Abhimanyu Study coordinator
- Numero di telefono: 855-281-2328
- Email: science@qualialife.com
Luoghi di studio
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California
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Carlsbad, California, Stati Uniti, 92008
- Qualia Life Sciences
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Oral Capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
|
Sperimentale: 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.
|
Oral capsules.
Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
Lasso di tempo: 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
Lasso di tempo: 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.
|
Baseline to Day 28
|
|
Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores
Lasso di tempo: 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.
|
Baseline to Day 28
|
|
Safety and tolerability profile
Lasso di tempo: 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.
|
Days 1, 3, 7, 14, 21, and 28
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Follow-Up Questionnaire (overall product experience and rating)
Lasso di tempo: 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.
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5-7 days after final dose
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: William Director of Research, Qualia Life Sciences
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
28 agosto 2026
Completamento primario (Stimato)
31 ottobre 2026
Completamento dello studio (Stimato)
31 ottobre 2026
Date di iscrizione allo studio
Primo inviato
29 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 luglio 2026
Primo Inserito (Effettivo)
4 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 agosto 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- QLS-024
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .