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Change in staffing and budget due to Covid-19
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| Name | Class |
|---|---|
| Parker Hannifin Corporation | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warming hydrogel glove | Device | Subjects wore the warming hydrogel glove in either the first or second two-week period. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency Assessed Via Sleep Log. | Sleep latency measured in minutes via subjective sleep log. | 2-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Ebben, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College Center for Sleep | New York | New York | 10065 | United States |
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The study utilizes a crossover design. Therefore, each subject is in both control and treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention (2 Weeks) |
| |||||||||||||
| 2nd Intervention (2 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Warming Hydrogel Glove, Then Non-thermal Glove |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Minutes | 2 weeks for each condition |
|
5-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-thermal Glove | Subject received the non-thermal glove in either the first or second 2-week period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew R. Ebben, Ph.D. | Weill Cornell Medicine | 646-962-9313 | mae2001@med.cornell.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Non-thermal glove | Device | Subjects wore the non-thermal glove in either the first or second two-week period. |
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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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Sleep Latency Assessed Via Sleep Log. | Sleep latency measured in minutes via subjective sleep log. | Posted | Mean | Standard Deviation | Minutes | 2-weeks |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Warming Hydrogel Glove | Subject received the warming hydrogel glove in either the first or second 2-week period of the study. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D001523 |
| Mental Disorders |