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| Name | Class |
|---|---|
| Cornell University | OTHER |
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This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), which is considered the gold standard for sleep assessment. This research is being done because if proven to accurately analyze sleep,these devices may make conducting in-home sleep studies easier and more affordable in the future.
This study seeks to validate three new commercial sleep monitoring devices: Fitbit, Jawbone UP, and Microsoft Band by comparison against concurrent polysomnography (PSG), considered the gold standard assessment for sleep physiology. The investigators emphasize here that the commercial sleep monitoring devices (Fitbit, Jawbone UP, and Microsoft Band) are used in addition to PSG and not in place of it. Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Data will be transferred from the sleep monitoring device(s) for later statistical analysis and comparison with scored polysomnogram. Device(s) will be cleaned (using antiseptic wipes), reset,recharged, and otherwise prepared for reuse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit | Active Comparator | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. |
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| Jawbone UP | Active Comparator | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. |
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| Microsoft Band | Active Comparator | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non dominant hand when prepared for the sleep study by a technician. Subjects willing to wear more than one sleep monitoring device may be fitted with two different sleep monitoring devices, e.g., a Fitbit and a Jawbone UP or a Fitbit and a Microsoft Band. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Device | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST). | 1 night, approximately 9 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL). | 1 night, approximately 9 hours. |
| Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Krieger, M.D., M.P.H | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine Center for Sleep Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fitbit Charge 2 | Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
| FG001 | Microsoft Band 2 | Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This arm was dropped due to cost restrictions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fitbit Charge 2 | Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
| 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 | Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST). | Posted | Mean | Standard Deviation | minutes | 1 night, approximately 9 hours. |
|
1 day - the day after the recording night when the device was worn
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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 | Fitbit Charge 2 | Willing subjects, after providing informed consent, will be fitted with Fitbit Charge 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Krieger | Weill Cornell Medical College | 6469629316 | ack2003@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol, Statistical Analysis Plan | Dec 14, 2015 | Jan 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
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| Jawbone UP | Device | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. |
|
| Microsoft Band | Device | Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician. |
|
Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO) |
| 1 night, approximately 9 hours. |
| Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE) | 1 night, approximately 9 hours. |
| BG001 | Microsoft Band 2 | Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Fitbit: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. |
|
|
|
| Secondary | Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL). | Posted | Mean | Standard Deviation | minutes | 1 night, approximately 9 hours. |
|
|
|
|
| Secondary | Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO) | Posted | Mean | Standard Deviation | minutes | 1 night, approximately 9 hours. |
|
|
|
|
| Secondary | Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE) | Posted | Mean | Standard Deviation | percentage of sleep efficiency | 1 night, approximately 9 hours. |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Microsoft Band 2 | Willing subjects, after providing informed consent, will be fitted with Microsoft Band 2 on the wrist of their non dominant hand when prepared for the sleep study by a technician. Sleep monitoring device(s) will be removed from the subject's wrist in the morning at the conclusion of the sleep study. Microsoft Band 2: Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |