To Sleep, Perchance to Dream: A Randomized, Placebo-Controlled Study to Test a Fruit/Honey-Based Foodstuff for Sleep Problems in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- PSQI score
研究概览
简要总结
As many as 57% of older adults complain of major disruption of sleep, 29% struggle to fall asleep and 19% complain of early-morning awakening. The implications of this sleep deprivation are sobering, particularly among older individuals.
The primary goal of this study is to determine whether a palatable foodstuff which contains a fruit/honey drink and which is taken every evening before bedtime leads to improved sleep in community-living individuals with sleep problems.
详细描述
This is a randomized, placebo-controlled double-blinded pilot study to explore the use of a fruit/honey drink product for improving sleep in older adults. The purpose of this study is to estimate the effects of a fruit/honey drink using various assessment tools when used as short-term intervention.
This trial proposes to enroll a total of 60 community based older adults. All study patients will be instructed to take the study product every day for 28 days. During which time, study subjects will return weekly to complete study visits for a total of 4 visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 60 years old at the time of study registration.
- •Individual describes trouble either falling asleep or staying asleep at study entry.
- •Willing to participate in all aspects of the study.
- •Willing to avoid kiwifruit, cherry, and honey for 4 weeks while on this study.
- •Willing to avoid changes to current sleep medications (may use a stable dose of a currently prescribe sleep medication during the first 4 weeks after stating the intervention).
排除标准
- •Allergic to kiwifruit, cherries, honey, apples, or bananas.
- •Hospitalized or living in a care facility at the time of enrollment.
- •Clinical evidence of active malignant disease (cancer), as per healthcare provider's clinical judgment.
- •Any cancer therapy (for example, chemotherapy, hormonal therapy, radiation, surgery, immunotherapy) in the preceding 3 months.
- •Healthcare provider does not think that study candidate has a specific health problem that precludes participation.
- •Allergy or intolerance of milk products.
- •Women of child bearing potential.
结局指标
主要结局
PSQI score
时间窗: 28 days
Pittsburgh Sleep Quality Index (PSQI):
次要结局
未报告次要终点
研究者
Brent A. Bauer
Principal Investigator
Mayo Clinic