Sleep Apnea
Conditions
Keywords
In lab sleep studies
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFitbit
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.
DEVICEJawbone UP
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.
DEVICEMicrosoft Band
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.
Sponsors
Cornell University
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine.
Exclusion criteria
* Not attending a regularly scheduled overnight polysomnography (PSG) sleep study at the Weill Cornell Medical College Center for Sleep Medicine. * Under 18 or over 80 years old. * Pregnancy * Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. | 1 night, approximately 9 hours. | Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. | 1 night, approximately 9 hours. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL). |
| Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. | 1 night, approximately 9 hours. | Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO) |
| Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. | 1 night, approximately 9 hours. | Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Fitbit Charge 2 | Microsoft Band 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 25 Participants | 62 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 75 Participants | 138 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 100 Participants | 100 Participants | 200 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 81 Participants |
| Sex: Female, Male Male | 58 Participants | 61 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
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).
Time frame: 1 night, approximately 9 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Charge 2 | Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. | 437.0 minutes | Standard Deviation 80.6 |
| Microsoft Band 2 | Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2. | 394.9 minutes | Standard Deviation 105.8 |
p-value: <0.001ANOVA
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)
Time frame: 1 night, approximately 9 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Charge 2 | Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. | 93.4 percentage of sleep efficiency | Standard Deviation 9.6 |
| Microsoft Band 2 | Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2. | 82.1 percentage of sleep efficiency | Standard Deviation 15.5 |
p-value: <0.001ANOVA
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).
Time frame: 1 night, approximately 9 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Charge 2 | Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. | 8.8 minutes | Standard Deviation 13.7 |
| Microsoft Band 2 | Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2. | 26.2 minutes | Standard Deviation 30.5 |
p-value: <0.001ANOVA
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)
Time frame: 1 night, approximately 9 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit Charge 2 | Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. | 30.3 minutes | Standard Deviation 42 |
| Microsoft Band 2 | Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2. | 88.0 minutes | Standard Deviation 71.7 |
p-value: <0.001ANOVA