Temperature Manipulating Gloves for the Treatment of Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Sleep Latency Assessed Via Actigraphy Monitoring
研究概览
简要总结
The investigators plan to test the effectiveness of warm gel gloves in reducing the time it takes individuals to fall asleep (sleep latency). The investigators will have subjects track their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called an actigraph to measure the degree of the persons' difficulty falling asleep. It must take at least 30-minutes to fall asleep 3-days per week to qualify for the study. If a subject qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. The baseline sleep latency data will be compared to the treatment period using a independent t-test. The investigators believe that wearing the warm gel gloves will reduce sleep latency.
详细描述
Insomnia affects anywhere from six percent to 33% of the U.S. population depending on the precision of the definition being used. Therefore, represents one of the most prevalent health concerns for Americans. Individuals with insomnia frequently report problems such as (but not limited to) difficulty focusing and concentrating, memory difficulties, impaired motor coordination, irritability and impaired social interactions. Moreover, chronic insomnia has also been associated with reduced quality of life, higher absenteeism, impaired job performance, and higher healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for each participant are as follows: Must be between 18 and 65 years old
- •Have difficulty initiating sleep for at least two-weeks, including a sleep latency of at least 30-minutes, three days per week (as measured by wrist actigraphy and/or sleep logs)
- •No history of a dermatological disorders or chronic pain conditions
- •Not currently using narcotics, psychotropic or hypnotic medications and willing to refrain from using these medications during the course of the study
- •Limits caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day
- •Limits alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night, must adjust alcohol consumption to 7-drinks per week and less than or equal to 1 drink on any one night for at least two weeks before study begins, and must not consume alcohol later than 8pm
- •Naps less than or equal to 1-hour per week according to subjective report
- •Must have a body mass index less than 30
- •Shift workers will not be accepted.
排除标准
- •History of a dermatological disorder
- •Using narcotics, psychotropic or hypnotic medications
- •Caffeine consumption greater than 2 coffee servings, or equivalent per day
- •Alcohol intake greater than 7 drinks per week and greater than 1 drink on any one night, consume alcohol later than 8pm
- •Naps greater than 1-hour per week according to subjective report
- •Body mass index greater than 30; Shift worker.
研究组 & 干预措施
Warming hydrogel glove, then non-thermal glove
In the first two-week period, subjects will wear a warming hydrogel glove. In the second two-week period, subjects will wear a non-thermal glove. Also a actigraph to monitor sleep latency.
干预措施: Warming hydrogel glove (Device)
Warming hydrogel glove, then non-thermal glove
In the first two-week period, subjects will wear a warming hydrogel glove. In the second two-week period, subjects will wear a non-thermal glove. Also a actigraph to monitor sleep latency.
干预措施: Non-thermal glove (Device)
Non-thermal glove, then warming hydrogel glove
In the first two-week period, subjects will wear a non-thermal glove. In the second two-week period, subjects will wear a warming hydrogel glove. Also an actigraph to monitor sleep latency.
干预措施: Warming hydrogel glove (Device)
Non-thermal glove, then warming hydrogel glove
In the first two-week period, subjects will wear a non-thermal glove. In the second two-week period, subjects will wear a warming hydrogel glove. Also an actigraph to monitor sleep latency.
干预措施: Non-thermal glove (Device)
结局指标
主要结局
Sleep Latency Assessed Via Actigraphy Monitoring
时间窗: 2 weeks for each condition
The Outcome Measure will be assessed via actigraphy monitoring. Sleep latency will be measured on the actigraphy monitoring device and measured twice; during a two-week control period (non-thermal glove) and during the two-week treatment period (thermal hydrogel glove).
次要结局
- Sleep Latency Assessed Via Sleep Log.(2-weeks)