Clinical trial NCT02341287: Temperature Manipulating Gloves for the Treatment of Insomnia
Official title: Temperature Manipulating Gloves for the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insomnia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Parker Hannifin Corporation
First posted: 2015-01-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Latency Assessed Via Actigraphy Monitoring
timeFrame: 2 weeks for each condition
Secondary outcomes:
measure: Sleep Latency Assessed Via Sleep Log.
timeFrame: 2-weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College Center for Sleep
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Matthew Ebben, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: