search
Back to results

Temperature Manipulating Gloves for the Treatment of Insomnia

Primary Purpose

Insomnia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warming hydrogel glove
Non-thermal glove
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Weill Cornell Medical College Center for Sleep

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Warming hydrogel glove, then non-thermal glove

Non-thermal glove, then warming hydrogel glove

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Sleep Latency Assessed Via Sleep Log.
Sleep latency measured in minutes via subjective sleep log.

Full Information

First Posted
December 18, 2014
Last Updated
September 6, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
Parker Hannifin Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02341287
Brief Title
Temperature Manipulating Gloves for the Treatment of Insomnia
Official Title
Temperature Manipulating Gloves for the Treatment of Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Change in staffing and budget due to Covid-19
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 7, 2016 (Actual)
Study Completion Date
April 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Parker Hannifin Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warming hydrogel glove, then non-thermal glove
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-thermal glove, then warming hydrogel glove
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Warming hydrogel glove
Intervention Description
Subjects wore the warming hydrogel glove in either the first or second two-week period.
Intervention Type
Device
Intervention Name(s)
Non-thermal glove
Intervention Description
Subjects wore the non-thermal glove in either the first or second two-week period.
Primary Outcome Measure Information:
Title
Sleep Latency Assessed Via Actigraphy Monitoring
Description
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).
Time Frame
2 weeks for each condition
Secondary Outcome Measure Information:
Title
Sleep Latency Assessed Via Sleep Log.
Description
Sleep latency measured in minutes via subjective sleep log.
Time Frame
2-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Ebben, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College Center for Sleep
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Temperature Manipulating Gloves for the Treatment of Insomnia

We'll reach out to this number within 24 hrs