The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
研究概览
简要总结
A home-based, sham-controlled, double-blind, crossover study evaluating the effects of wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep measures, proximal skin temperature, and sternal skin moisture in menopausal women complaining of sleep disturbance and vasomotor symptoms.
详细描述
Sixteen menopausal women who have given informed consent to participate will be medically screened to rule out physiological sleep disorders. Sleep schedules will be regulated to the average bedtime of a two-week baseline sleep log. Subjects will undergo two two-night, home-based monitoring phases, one an experimental and one a control condition, separated by a washout period of at least five nights. The order of conditions will be counterbalanced between subjects in double-blind fashion. In the experimental condition subjects will wear sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex insulating material on one side and specialized conductive material on the other. In the control condition subjects will wear sleepwear that is similarly lateralized in terms of appearance but constructed with typical cotton spandex insulating material on both sides. Ambulatory monitoring will include body position, EEG, actigraphy, skin temperature at multiple proximal sites, and sternal skin moisture. Subjective scales of insomnia severity, menopausal symptoms and sleepwear rating will also be employed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Treatment and sham-control sleepwear will be allocated to subjects in a counterbalanced manner by a study administrator who will not otherwise interact with subjects.
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 12 months since last menstrual period
- •Subjective complaint of sleep disturbance, confirmed by Pittsburgh Sleep Quality Index score greater than 5
- •Subjective complaint of at least moderate symptoms of menopause, confirmed by modified Kupperman score greater than 15
- •Ability to sleep in the left lateral, right lateral and supine positions
排除标准
- •Unable to taper off, with health care provider's agreement, hypnotic or sedative medications, hormone replacement therapy, clonidine, gabapentin, or isoflavones and other botanical compounds used to treat vasomotor symptoms of menopause
- •Unable to taper to two or fewer caffeinated beverages per day
- •Unable to taper to one or fewer alcoholic beverages per day
- •Unable to taper off nicotine in any form
- •Unable to taper off recreational drugs
- •Subjective sleep, based on two-week sleep logs, averaging less than 4.0 or greater than 7.5 hours per night
- •Clinical suspicion of obstructive sleep apnea, periodic leg movements or other significant physiological sleep disturbance
- •Known skin allergy to silver, cotton, nylon, surgical tape and other adhesives
研究组 & 干预措施
Lateralized Thermal Sleepwear
For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics
干预措施: Sleepwear with Lateralized Thermal Characteristics (Device)
Sham-Lateralized Sleepwear
For two consecutive nights subjects will wear Sham-Lateralized Sleepwear
干预措施: Sham-Lateralized Sleepwear (Device)
结局指标
主要结局
Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
时间窗: Two nights in the experimental condition and two nights in the control condition.
Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.
Total Sleep Time
时间窗: Two nights in the experimental condition and two nights in the control condition.
Minutes of sleep of any stage, as scored by conventional criteria, across recording period.
Wakefulness After Sleep Onset
时间窗: Two nights in the experimental condition and two nights in the control condition.
Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.
次要结局
- Proximal Skin Temperature(Measurements taken every 90 seconds across two-night experimental and control conditions)
研究者
Paul Glovinsky, Ph.D.
Clinical Director, St. Peter's Sleep Center
St. Peter's Hospital, Albany, NY