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Temperature Manipulating Gloves for the Treatment of Insomnia

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ClinicalTrials.gov Identifier: NCT02341287
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Parker Hannifin Corporation
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Insomnia Device: Warming hydrogel device Device: Non thermal hydrogel device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Temperature Manipulating Gloves for the Treatment of Insomnia
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: Warming hydrogel glove

Patients will wear a warming hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.

Warming hydrogel device

Device: Warming hydrogel device
Patients will wear a warming hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.

Placebo Comparator: Non thermal hydrogel glove

Patients will wear a hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.

Non thermal hydrogel device

Device: Non thermal hydrogel device
Patients will wear a hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.




Primary Outcome Measures :
  1. Baseline Sleep Latency, assessed via actigraphy monitoring [ Time Frame: 2 weeks ]
    Participants will be followed for the duration of the study an expected average of five weeks. The Outcome Measure will be assessed via actigraphy monitoring. Sleep latency will be measured on the actigraphy monitoring device and measured twice, once during a two-week baseline period and once during the two-week device period.


Secondary Outcome Measures :
  1. Device period sleep latency, assessed via actigraphy monitoring [ Time Frame: 4 weeks ]
    Participants will be followed for the duration of the study an expected average of five weeks. The Outcome Measure will be assessed via actigraphy monitoring. Sleep latency will be measured on the actigraphy monitoring device and measured twice, once during a two-week baseline period and once during the two-week device period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341287


Contacts
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Contact: Matthew Ebben, Ph.D. 646-962-7378 mae2001@med.cornell.edu
Contact: Josue Roseus, B.A. 347-720-3173 jor4007@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medical College Center for Sleep Recruiting
New York, New York, United States, 10065
Contact: Dr. Matthew R Ebben, Ph.D    646-962-7378    mae2001@med.cornell.edu   
Contact: Josue Roseus, B.A.    347-720-3173    jor4007@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Parker Hannifin Corporation
Investigators
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Principal Investigator: Matthew Ebben, Ph.D. Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02341287     History of Changes
Other Study ID Numbers: 1301013445
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders