Temperature Manipulating Gloves for the Treatment of Insomnia

NCT02341287 | Terminated Results FDA Device

• 1 other identifier: 1301013445
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sleep Latency Assessed Via Sleep Log.

  2-weeks

Study Arms (2)

Warming hydrogel glove, then non-thermal glove

ACTIVE COMPARATOR

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; Device: Non-thermal glove

Non-thermal glove, then warming hydrogel glove

PLACEBO COMPARATOR

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; Device: Non-thermal glove

Interventions

Warming hydrogel glove DEVICE

Subjects wore the warming hydrogel glove in either the first or second two-week period.

Non-thermal glove, then warming hydrogel glove; Warming hydrogel glove, then non-thermal glove

Non-thermal glove DEVICE

Subjects wore the non-thermal glove in either the first or second two-week period.

Non-thermal glove, then warming hydrogel glove; Warming hydrogel glove, then non-thermal glove

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Parker Hannifin Corporation: collaborator

Study Sites (1)

Weill Cornell Medical College Center for Sleep

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Matthew R. Ebben, Ph.D.
• Organization: Weill Cornell Medicine

mae2001@med.cornell.edu

646-962-9313

Study Officials

• Matthew Ebben, Ph.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: April 7, 2016
• Study Completion: April 7, 2016
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)