Sleep Quality
Conditions
Keywords
sleep quality, pre-sleep arousal, sleep-related daytime impairment, dietary supplement
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTQualia Sleep Formula A
Oral Capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
DIETARY_SUPPLEMENTQualia Sleep Formula B
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
DIETARY_SUPPLEMENTQualia Sleep Formula C
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
DIETARY_SUPPLEMENTQualia Sleep Formula D
Oral capsules. Dosage: 2 capsules once daily at night, 30-60 minutes before bed, for 28 days.
Sponsors
Qualia Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup | Baseline to Day 28 | Change in PROMIS-SD in a subgroup with more pronounced baseline sleep disturbance. |
| Change from baseline in PROMIS Sleep-Related Impairment v1.0 Short Form 8a (PROMIS-SRI) score | 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. |
| Change from baseline in Pre-Sleep Arousal Scale (PSAS) somatic and cognitive arousal scores | 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. |
| Safety and tolerability profile | 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. |
Countries
United States
Contacts
CONTACTWilliam Director of Research
CONTACTAbhimanyu Study coordinator
PRINCIPAL_INVESTIGATORWilliam Director of Research
Qualia Life Sciences
Outcome results
None listed