Effect of Bonafide Sleep Supplement on Sleep Parameters in Menopausal Women With Sleep Complaints: An Open-Label Experience Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
研究概览
简要总结
This open-label study was designed to evaluate whether a daily dietary sleep supplement could improve sleep quality and related daytime well-being in menopausal women aged 40 to 65 with sleep complaints. All participants received the study supplement for approximately 12 weeks, followed by a four-week period without the supplement to assess changes after discontinuation. Sleep quality, sleep and well-being complaints, product experience, safety, and tolerability were assessed throughout the study.
详细描述
This is an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep quality and related well-being in perimenopausal and postmenopausal women with sleep complaints. The study was designed to enroll approximately 150 women aged 40 to 65 from across the United States. All participants received the study supplement, and all study procedures were conducted remotely.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep complaints, and eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days to familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in period, participants initiated the intervention on Day 1 and self-administered the study product once daily through approximately Day 85. The study product was administered orally as two tablets approximately 60 minutes before bedtime. Participants continued supplementation for approximately 12 weeks through the End of Intervention visit.
Throughout the intervention period, participants completed electronic questionnaires assessing sleep quality and related sleep and well-being complaints. Sleep quality was assessed regularly using visual analog scales, and sleep and well-being complaints were assessed at protocol-defined intervals. Participant experience with the study product was also evaluated near the end of the intervention period.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Study assessments continued during this period to characterize changes following discontinuation, and participants completed a washout questionnaire at the End of Study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women who are 40 to 65 years of age (inclusive).
- •Have a body mass index (BMI) between 18.5 to 39.9 kg/m2 (inclusive).
- •Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 55 (equivalent to a raw score of 25).
- •Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status. Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening. Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
- •In good general health (no uncontrolled diseases or conditions) and able to consume the study product.
- •Agree to refrain from treatments listed in Section 12.4 in the defined timeframe.
- •Has stable access to Wi-Fi and an iPhone or Android device.
- •Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
排除标准
- •Individuals who are lactating, pregnant, or planning to become pregnant during the study.
- •Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
- •Currently incarcerated prisoners.
- •Currently enrolled in a different clinical trial.
- •Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.
- •Participants whose insomnia is predominantly attributed to significant medical, psychiatric, or environmental factors (e.g., restless leg syndrome, sleep apnea, chronic pain, anxiety, depression, or shift work) may be excluded, at the discretion of the investigator, if it is determined that these factors could interfere with study outcomes or participant safety.
- •Have a known sensitivity, intolerability, or allergy to the study product or their excipients.
- •History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study or influence the results or the potential subject's ability to participate in the study.
- •Major surgery in one month prior to screening or planned major surgery during the study.
- •Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant. Note: screened participants with infections would be eligible to participate four weeks after completing their treatment (wash-out period).
研究组 & 干预措施
Bonafide Sleep
Participants received Bonafide Sleep orally as two tablets once daily approximately 60 minutes before bedtime from Day 1 through Day 85. After the intervention period, participants discontinued the study product and entered a washout period through Day 113.
干预措施: S-Adenosyl Methionine (SAMe), Propyl Gallate, Gamma-Aminobutyric Acid (GABA), L-Theanine, and Magnesium Glycinate (Dietary Supplement)
结局指标
主要结局
Change in Morning Ease as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported difficulty leaving bed and beginning the day, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no difficulty, while a score of 100 indicates extreme difficulty that is nearly impossible to overcome. Lower scores indicate greater ease beginning the day.
Change in Sleep-Onset Latency as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported time required to fall asleep, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates falling asleep almost immediately, while a score of 100 indicates substantial difficulty falling asleep. Lower scores indicate easier sleep initiation.
Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported frequency of sleep disturbances measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no sleep disturbances and peaceful sleep every night, while a score of 100 indicates constant sleep disturbances every night. Lower scores indicate fewer sleep disturbances.
Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported difficulty returning to sleep after awakening during the night, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no nighttime awakening, while a score of 100 indicates finding it very difficult or impossible to fall back asleep. Lower scores indicate better sleep maintenance.
Change in Mental Confusion as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported mental confusion upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no mental confusion and clear, focused thoughts, while a score of 100 indicates intense mental confusion and substantial difficulty achieving clarity. Lower scores indicate less mental confusion.
Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported morning grogginess measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates no grogginess and feeling fully alert upon waking, while a score of 100 indicates intense morning grogginess with marked drowsiness and lethargy. Lower scores indicate less morning grogginess.
Change in Restfulness or Rejuvenation as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported restfulness or rejuvenation upon waking, measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling fully rested and rejuvenated, while a score of 100 indicates no sense of restfulness or rejuvenation. Lower scores indicate greater restfulness.
Change in Deep Sleep as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported experience of deep, restorative sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates consistently experiencing deep, uninterrupted, restorative sleep, while a score of 100 indicates experiencing no perceived deep sleep. Lower scores indicate greater perceived deep sleep.
Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported daytime sleepiness measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates feeling alert and energetic without daytime sleepiness, while a score of 100 indicates an overpowering urge to sleep or nap. Lower scores indicate less daytime sleepiness.
Change in Sleep Satisfaction as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported satisfaction with sleep measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates being extremely satisfied with sleep, while a score of 100 indicates being extremely dissatisfied. Lower scores indicate greater sleep satisfaction.
Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported overall sleep quality measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent sleep quality, while a score of 100 indicates extremely poor sleep quality. Lower scores indicate better sleep quality.
Change in Overall Quality of Life as Measured by a Visual Analog Scale (VAS)
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 7 days
Change from baseline in self-reported overall quality of life measured using a visual analog scale (VAS) ranging from 0 to 100. A score of 0 indicates excellent quality of life and complete satisfaction, while a score of 100 indicates extremely poor quality of life and no satisfaction. Lower scores indicate better perceived quality of life.
Change in Sleep and Well-Being Complaints Questionnaire Responses
时间窗: Baseline (Day 1) through Week 16 (Day 113 ±3 days), assessed every 28 days
Change from baseline in participant-reported sleep and well-being complaints. The questionnaire assesses sleep initiation and latency, sleep maintenance and quality, morning refreshment and energy, daytime functioning and cognitive clarity, and emotional and physical well-being. Individual complaints are assessed as present or absent, with severity rated from 0 to 100 when a complaint is endorsed.
Participant Experience With the Study Product
时间窗: Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days)
Participant responses to the Product Experience Questionnaire assessing overall satisfaction with the study product, ease of use, perceived effects on sleep and daytime functioning, overall product experience, and willingness to recommend or continue using the product. Scored Likert items range from 1 (Strongly Disagree) to 4 (Strongly Agree), with higher scores indicating a more favorable product experience. Selected items include 0 = Not Applicable, which is not treated as a scored response. Additional items use Yes/No/Not Applicable or open-text responses. No composite total score is calculated; responses are summarized by individual item.
Participant-Reported Changes Following Study Product Discontinuation
时间窗: Week 16 (Day 113 ±3 days), following approximately 4 weeks of study product discontinuation
Participant responses to the Washout Questionnaire assessing perceived changes following discontinuation of the study product, including sleep quality, daytime restfulness and energy, cognitive function, mood, overall satisfaction, perceived product benefit, and likelihood of recommending the product. The questionnaire uses item-specific ordered categorical response options, including 4-level responses (e.g., Very Dissatisfied to Very Satisfied; Strongly Disagree to Strongly Agree) and 5-level responses (e.g., Not Effective to Very Effective; Much Worse to Much Better; Definitely Not to Definitely Yes). More favorable response categories indicate a more favorable perceived outcome. No composite total score or single minimum/maximum questionnaire score is calculated; responses are summarized by individual item.
次要结局
未报告次要终点