Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
10 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: William Director of Research
- Telefonnummer: 855-281-2328
- E-post: science@qualialife.com
Studera Kontakt Backup
- Namn: Abhimanyu Study coordinator
- Telefonnummer: 855-281-2328
- E-post: science@qualialife.com
Studieorter
-
-
California
-
Carlsbad, California, Förenta staterna, 92008
- Qualia Life Sciences
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Follow-Up Questionnaire (overall product experience and rating)
Tidsram: 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.
|
5-7 days after final dose
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: William Director of Research, Qualia Life Sciences
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
28 augusti 2026
Primärt slutförande (Beräknad)
31 oktober 2026
Avslutad studie (Beräknad)
31 oktober 2026
Studieregistreringsdatum
Först inskickad
29 juli 2026
Först inskickad som uppfyllde QC-kriterierna
29 juli 2026
Första postat (Faktisk)
4 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 augusti 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- QLS-024
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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