Effect of Bonafide Sleep Supplement on Sleep Parameters in Menopausal Women With Impaired Sleep: 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
- 90
- 试验地点
- 1
- 主要终点
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score
研究概览
简要总结
This open-label study evaluated whether a daily dietary sleep supplement could improve sleep and related daytime functioning in menopausal women aged 40 to 65 with impaired sleep. Participants used the supplement for approximately 12 weeks, followed by a four-week period without the supplement to evaluate changes after discontinuation. Sleep, daytime functioning, product experience, safety, and tolerability were assessed throughout the study.
详细描述
This was an open-label, single-group clinical trial conducted to evaluate the effects of a dietary sleep supplement on subjective sleep disturbance, sleep-related parameters, cognitive function, and well-being in perimenopausal and postmenopausal women with impaired sleep. All participants received the investigational dietary supplement.
Following electronic informed consent, participants completed a screening phase conducted via virtual visit, during which medical history, sleep disturbance, and other study eligibility criteria were assessed. Eligible participants then entered a run-in period of approximately seven days, during which they completed daily electronic sleep diaries to establish baseline sleep patterns and familiarize themselves with study procedures. No study product was consumed during the run-in period.
After completion of the run-in phase, participants initiated the intervention period 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 daily electronic sleep diaries and periodic electronic questionnaires assessing changes in sleep disturbance, sleep quality, cognitive function, daytime functioning, and overall well-being. Assessments were conducted at baseline and at regular intervals throughout the intervention period according to the protocol-defined schedule of activities. Participant experience with the study product was also assessed during the study.
Following completion of the intervention period, participants discontinued the study product and entered a washout period from approximately Day 86 through Day 113. Participants continued completing study assessments during this period to characterize changes in sleep and related outcomes after supplementation ended. A washout questionnaire was administered at the End of Study visit to evaluate participants' perceptions of changes in sleep, mood, cognitive function, and overall experience following discontinuation of the study product.
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 34.9 kg/m2 (inclusive).
- •Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
- •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 active or 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.
- •Previous use of SAMe, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
- •Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.
- •Taking blood thinners within the last 2 weeks. Further details may be found in Section 12.
- •Have a known sensitivity, intolerability, or allergy to the study product or their excipients.
- •Received a vaccine for COVID-19 in the two weeks prior to screening or during the study period, current COVID-19 infections, or currently have the post-COVID-19 condition as defined by World Health Organization (WHO) (i.e., individuals with a history of probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis).
- •Have a positive medical history of heart disease, renal disease, hepatic impairment, or active systemic infection (e.g., Lyme disease, TB, HIV).
- •History of cancer (except localized skin cancer without metastases) within two (2) years prior to screening.
- •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.
- •History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
- •Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- •Major surgery in three months prior to screening or planned major surgery during the study.
- •Currently diagnosed with depression by a doctor or physician.
- •Have been or currently diagnosed with bipolar disorder by a doctor or physician.
- •History of epilepsy or taking epileptic medications.
- •Presence of sleep disorders that have been diagnosed by a doctor or physician.
- •Currently using any sleep device (e.g., nebulizer machine, sleep apnea masks, continuous positive airway pressure (CPAP)) to improve sleep.
- •Recent shift work, night work, or frequent travel to different time zones in the past month, which, in the opinion of the investigator, may adversely affect the participant's sleep quality.
- •Consumption of more than 400 mg of caffeine per day.
- •History of alcohol or substance abuse in the last 5 years.
- •Report ≥ 14-night sweats per week.
- •Report ≥ 20 hot flashes per week.
- •Have animals that frequently cause sleep disturbances
- •Have partners who regularly disturb their sleep
- •Have young children or infants who frequently require caregiving responsibilities and disturb sleep
- •Planned travel during the study period that, in the opinion of the investigator, may negatively influence the participant's sleep.
- •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 Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form T-Score
时间窗: Baseline (Day 1) through Day 113 (±3 days)
Change from baseline in the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) T-score. The PROMIS SD SF assesses self-reported perceptions of sleep, including difficulty getting to or staying asleep, sleep satisfaction, and overall sleep quality over the prior seven days.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Cognitive Function Short Form T-Score
时间窗: Baseline (Day 1) through Day 113 (±3 days)
Change from baseline in the Patient-Reported Outcomes Measurement Information System Cognitive Function Short Form (PROMIS CF SF) T-score. The PROMIS CF SF assesses perceived cognitive abilities in everyday activities, including memory, attention, and mental clarity.
Change in Pittsburgh Sleep Quality Index (PSQI) Score
时间窗: Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score. The PSQI is a validated patient-reported instrument assessing sleep quality and disturbances over a one-month period, including sleep duration, sleep latency, habitual sleep efficiency, sleep disturbances, and overall subjective sleep quality.
次要结局
- Change in Sleep and Well-Being Complaints Questionnaire Responses(Baseline (Day 1) through Day 113 (±3 days), assessed every 28 days)
- Participant-Reported Changes Following Study Product Discontinuation(Week 16 (Day 113 ±3), following approximately 4 weeks of study product discontinuation)
- Participant Experience With the Study Product(Week 12 (Day 85 ± 3 days) and Week 16 (Day 113 ± 3 days))
- Change in Total Sleep Time (TST)(Day -7 (run-in baseline) through Day 113 (±3 days))
- Change in Sleep Disturbances(Day -7 (run-in baseline) through Day 113 (±3 days))
- Change in Wake After Sleep Onset (WASO)(Day -7 (run-in baseline) through Day 113 (±3 days))
- Change in Sleep-Onset Latency (SOL)(Day -7 (run-in baseline) through Day 113 (±3 days))
- Change in Daytime Sleepiness(Day -7 (run-in baseline) through Day 113 (±3 days))
- Change in Sleep Quality as Measured by a Visual Analog Scale (VAS)(Baseline (Day 1) through Day 113 (±3 days))
- Change in Sleep Disturbances as Measured by a Visual Analog Scale (VAS)(Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days)
- Change in Wakefulness After Sleep Onset (WASO) as Measured by a Visual Analog Scale (VAS)(Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days)
- Change in Morning Ease as Measured by a Visual Analog Scale (VAS)(Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days)
- Change in Morning Grogginess as Measured by a Visual Analog Scale (VAS)(Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days)
- Change in Daytime Sleepiness as Measured by a Visual Analog Scale (VAS)(Baseline through Week 16 (Day 113 ±3 days), assessed every 7 days)