Insomnia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEWarming hydrogel glove
Subjects wore the warming hydrogel glove in either the first or second two-week period.
DEVICENon-thermal glove
Subjects wore the non-thermal glove in either the first or second two-week period.
Sponsors
Parker Hannifin Corporation
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Latency Assessed Via Actigraphy Monitoring | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Latency Assessed Via Sleep Log. | 2-weeks | Sleep latency measured in minutes via subjective sleep log. |
Countries
United States
Participant flow
Pre-assignment details
The study utilizes a crossover design. Therefore, each subject is in both control and treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Non-thermal Glove, Then Warming Hydrogel Glove | Warming Hydrogel Glove, Then Non-thermal Glove | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Sleep Latency Assessed Via Actigraphy Monitoring
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).
Time frame: 2 weeks for each condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-thermal Glove | Sleep Latency Assessed Via Actigraphy Monitoring | 58.40 Minutes | Standard Deviation 25.29 |
| Warming Hydrogel Glove | Sleep Latency Assessed Via Actigraphy Monitoring | 44.39 Minutes | Standard Deviation 21.23 |
p-value: 0.02395% CI: [2.29, 25.74]t-test, 2 sided
Secondary
Sleep Latency Assessed Via Sleep Log.
Sleep latency measured in minutes via subjective sleep log.
Time frame: 2-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-thermal Glove | Sleep Latency Assessed Via Sleep Log. | 56.36 Minutes | Standard Deviation 23.56 |
| Warming Hydrogel Glove | Sleep Latency Assessed Via Sleep Log. | 42.84 Minutes | Standard Deviation 23.6 |
p-value: <0.01495% CI: [3.29, 23.73]t-test, 2 sided