Temperature Manipulating Gloves for the Treatment of Insomnia

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia
• Intervention / Treatment: Device: Warming hydrogel glove; Device: Non-thermal glove

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College Center for Sleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Warming hydrogel glove, then 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.	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.
PLACEBO_COMPARATOR: Non-thermal glove, then 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Latency Assessed Via Sleep Log.	Sleep latency measured in minutes via subjective sleep log.	2-weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Parker Hannifin Corporation

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (ACTUAL): April 7, 2016
• Study Completion (ACTUAL): April 7, 2016

Study Registration Dates

• First Submitted: December 18, 2014
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (ESTIMATE): January 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 1301013445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes