NCT02341287

Temperature Manipulating Gloves for the Treatment of Insomnia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	Warming hydrogel glove	Subjects wore the warming hydrogel glove in either the first or second two-week period.
DEVICE	Non-thermal glove	Subjects wore the non-thermal glove in either the first or second two-week period.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-07
• Completion: 2016-04-07
• First posted: 2015-01-19
• Last updated: 2022-10-04
• Results posted: 2022-10-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study