Comparison of Four Qualia Sleep Formulations on Sleep Quality : An Open-label 4-arm Pilot Study
2026년 8월 10일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: William Director of Research
- 전화번호: 855-281-2328
- 이메일: science@qualialife.com
연구 연락처 백업
- 이름: Abhimanyu Study coordinator
- 전화번호: 855-281-2328
- 이메일: science@qualialife.com
연구 장소
-
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California
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Carlsbad, California, 미국, 92008
- Qualia Life Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
실험적: 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.
|
|
실험적: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance v1.0 Short Form 8b (PROMIS-SD) score
기간: Baseline to Day 28
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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.
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Baseline to Day 28
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change from baseline in PROMIS Sleep Disturbance (PROMIS-SD) score in the higher-disturbance subgroup
기간: 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
기간: 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
기간: 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
기간: 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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Follow-Up Questionnaire (overall product experience and rating)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: William Director of Research, Qualia Life Sciences
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 28일
기본 완료 (추정된)
2026년 10월 31일
연구 완료 (추정된)
2026년 10월 31일
연구 등록 날짜
최초 제출
2026년 7월 29일
QC 기준을 충족하는 최초 제출
2026년 7월 29일
처음 게시됨 (실제)
2026년 8월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- QLS-024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
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아니
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