Temperature Manipulating Gloves for the Treatment of Insomnia

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Insomnia

Treatments: Device: Non-thermal glove; Device: Warming hydrogel glove

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02341287

1301013445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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13 participants in 2 patient groups, including a placebo group

Warming hydrogel glove, then non-thermal glove

Active Comparator group

Description:

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.

Treatment:

Device: Non-thermal glove

Device: Warming hydrogel glove

Non-thermal glove, then warming hydrogel glove

Placebo Comparator group

Description:

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.

Treatment:

Device: Non-thermal glove

Device: Warming hydrogel glove