Temperature Manipulating Gloves for the Treatment of Insomnia

Not Applicable

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Non-thermal glove, then warming hydrogel glove	Non-thermal 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.
Warming hydrogel glove, then non-thermal glove	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.
Non-thermal glove, then warming hydrogel glove	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.
Warming hydrogel glove, then non-thermal glove	Warming hydrogel 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sleep Latency Assessed Via Sleep Log.	2-weeks	Sleep latency measured in minutes via subjective sleep log.

Locations (1): Weill Cornell Medical College Center for Sleep
🇺🇸
New York, New York, United States