Temperature Manipulating Gloves for the Treatment of Insomnia
| Status: | Recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2018 |
| Start Date: | May 2015 |
| End Date: | December 2019 |
| Contact: | Matthew Ebben, Ph.D. |
| Email: | mae2001@med.cornell.edu |
| Phone: | 646-962-7378 |
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.
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.
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.
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.
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.
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