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During last years, numerous sleep trackers have been commercialized. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep.
For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).
The purpose of the present study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.
During last years, numerous sleep trackers have been commercialized. They are working on accelerometer-based technology. They are intended to give indications about sleep quality/duration in order to give people an internet-based feedback about their own sleep..
For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used routinely to assess objective sleep quality/patterns. Their use is also validated to estimate sleep in obstructive sleep apnea syndrome (OSA).
The purpose of our study is to compare the accuracy of consumer-level sleep trackers and validated tools to measure sleep in OSA patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jawbone/Withings sleep trackers, Bodymedia Sensewear | Experimental | 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jawbone sleep tracker | Device | During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in Bed | time spent in bed during the night (minutes) | one night (up to 600 minutes) |
| Sleep Efficiency | a percentage corresponding to total sleep time divided by time in bed | one night (up to 600 minutes) |
| Total Sleep Time | time spent sleeping during the night (minutes) | one night (up to 600 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Deep Sleep | a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time | one night (up to 600 minutes) |
| Light Sleep | a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Bruyneel, MD PhD | Centre Hospitalier Universitaire Saint Pierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHu Saint Pierre | Brussels | 1000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Jawbone/Withings Sleep Trackers, Bodymedia Sensewear | 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Jawbone/Withings Sleep Trackers, Bodymedia Sensewear | 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
| 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 | Time in Bed | time spent in bed during the night (minutes) | Posted | Mean | Standard Deviation | min | one night (up to 600 minutes) |
|
one night, up to 600 minutes
22 participants were at risk for any adverse events, as usually described
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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 | Jawbone/Withings Sleep Trackers, Bodymedia Sensewear | 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Marie Bruyneel | CHU Saint-pierre | 00325354219 | marie_bruyneel@stpierre-bru.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2020 | Jan 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2020 | Jan 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| Withings sleep tracker | Device | During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
|
| BodyMedia Sense Wear accelerometer | Device | During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient |
|
| one night (up to 600 minutes) |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Sleep Efficiency | a percentage corresponding to total sleep time divided by time in bed | Posted | Mean | Standard Deviation | percentage of time in bed | one night (up to 600 minutes) |
|
|
|
| Primary | Total Sleep Time | time spent sleeping during the night (minutes) | Posted | Mean | Standard Deviation | min | one night (up to 600 minutes) |
|
|
|
| Secondary | Deep Sleep | a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time | Posted | Mean | Standard Deviation | a percentage of total sleep time | one night (up to 600 minutes) |
|
|
|
| Secondary | Light Sleep | a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time | Posted | Mean | Standard Deviation | a percentage of total sleep time | one night (up to 600 minutes) |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Withings sleep tracker |
|
| Title | Measurements |
|---|---|
|
| Withings sleep tracker |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|