InsomniaNCT02341287
Temperature Manipulating Gloves for the Treatment of Insomnia
A study testing Warming hydrogel glove and Non-thermal glove in people with Insomnia, run by Weill Medical College of Cornell University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Warming hydrogel glove and Non-thermal glove
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 7 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College Center for Sleep
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Warming hydrogel glove, Non-thermal glove
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warming hydrogel gloveDevice
Subjects wore the warming hydrogel glove in either the first or second two-week period.
Non-thermal gloveDevice
Subjects wore the non-thermal glove in either the first or second two-week period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Warming hydrogel glove; Device: Non-thermal glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks for each condition
Secondary outcomes (1)
Sleep Latency Assessed Via Sleep Log.
Sleep latency measured in minutes via subjective sleep log.
Measured: 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMay 2015
- Primary completion7 Apr 2016
- Study completion7 Apr 2016
Why it stopped: Change in staffing and budget due to Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Parker Hannifin Corporation
- Responsible party
- Sponsor
- Investigators
- Matthew Ebben, Ph.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341287
- Sponsor's protocol ID
- 1301013445
- Status last verified
- Sep 2022
- First submitted
- 18 Dec 2014
- Last updated
- 4 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Manipulating Gloves for the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT02341287
- Acronym / sponsor ID
- 1301013445
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in staffing and budget due to Covid-19
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Parker Hannifin Corporation
- Study start
- May 2015
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 4 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warming hydrogel glove, then non-thermal glove | Active comparator | Device: Warming hydrogel glove, Device: Non-thermal gloveIn 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. |
| Non-thermal glove, then warming hydrogel glove | Placebo comparator | Device: Warming hydrogel glove, Device: Non-thermal gloveIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warming hydrogel gloveSubjects wore the warming hydrogel glove in either the first or second two-week period. | Device | Non-thermal glove, then warming hydrogel glove, Warming hydrogel glove, then non-thermal glove |
| Non-thermal gloveSubjects wore the non-thermal glove in either the first or second two-week period. | Device | Non-thermal glove, then warming hydrogel glove, Warming hydrogel glove, then non-thermal glove |
Primary outcome
Sleep Latency Assessed Via Actigraphy Monitoring
Time frame: 2 weeks for each condition
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).
1 secondary outcome
Sleep Latency Assessed Via Sleep Log.
Time frame: 2-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Ebben, Ph.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warming hydrogel glove and Non-thermal glove in people with Insomnia, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Latency Assessed Via Actigraphy Monitoring (time frame: 2 weeks for each condition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.