MUSE Device to Improve Sleep Quality in Midlife Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in Quality of Sleep
研究概览
简要总结
The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in the menopause transition or in menopause, based on clinical assessment
- •PSQI score > 5, with overall sleep quality rating of "fairly bad" or "very bad".
- •Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.
- •Access to an iPad, iPhone, or android device.
- •Have ability to provide informed consent.
排除标准
- •Suspected or untreated obstructive sleep apnea.
- •Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity).
- •Use of hormone therapy or hypnotic agents.
- •Use of supplements known to affect sleep.
- •A known, active, untreated clinically significant psychiatric condition.
- •Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
- •Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
研究组 & 干预措施
Muse-S headband system for management of sleep disturbances
Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.
干预措施: Muse-S™ headband system (Device)
结局指标
主要结局
Change in Quality of Sleep
时间窗: Baseline, 3 months, 6 months
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Sleep Impact
时间窗: Baseline, 3 months, 6 months
Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.
次要结局
- Perceived Stress Levels(Baseline, 3 months, 6 months)
- Change in Perceived Anxiety(Baseline, 3 months, 6 months)
- Sexual Function(Baseline, 3 months, 6 months)
- Sexual Distress(Baseline, 3 months, 6 months)
- Change in Quality of Life(Baseline, 3 months, 6 months)
研究者
Amber L. Klindworth
Principal Investigator
Mayo Clinic