Temperature Manipulating Gloves for the Treatment of Insomnia

Insomnia Clinical Trial

Official title:

Temperature Manipulating Gloves for the Treatment of Insomnia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02341287
• Other study ID #: 1301013445
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 7, 2016

Study information

• Verified date: September 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 7, 2016
• Est. primary completion date: April 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Warming hydrogel glove
Subjects wore the warming hydrogel glove in either the first or second two-week period.
• Non-thermal glove
Subjects wore the non-thermal glove in either the first or second two-week period.

Locations

Country	Name	City	State
United States	Weill Cornell Medical College Center for Sleep	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Parker Hannifin Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Latency Assessed Via Actigraphy Monitoring	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).	2 weeks for each condition
Secondary	Sleep Latency Assessed Via Sleep Log.	Sleep latency measured in minutes via subjective sleep log.	2-weeks