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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| Itamar-Medical, Israel | INDUSTRY |
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Validation study of a novel sleep Device compared to a traditional sleep study.
This is an investigator-initiated validation study for the WatchPAT 200 device compared to the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately, the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild sleep apnea architecture will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WatchPAT Intervention | Other | Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WatchPAT Intervention | Device | Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) | Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more. | Up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) | Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep. | Up to 10 hours |
| Oxygen Desaturation Index (ODI) |
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Inclusion Criteria:
Age 5 through 12 years of age.
Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as:
Informed consent obtained.
Exclusion Criteria:
Medical conditions that can affect the tonometer reading such as:
Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
History of neuromuscular malformation
History of current supplemental oxygen use
History of current vasoactive, cardiac or seizure medication use
Inability or unwillingness to provide informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Sobremonte-King, MD | University of Colorado, Denver | Principal Investigator |
| Ann Halbower, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | WatchPAT Intervention | Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 8 participants who did not complete the study are excluded from the baseline characteristics data.
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| ID | Title | Description |
|---|---|---|
| BG000 | WatchPAT Intervention | Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram. |
| 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 | Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) | Compare the results to the subjects clinical sleep study results. The PAHI measures presence of sleep apnea. Scores are counts of respiratory events per hour. A score of more than 2 indicates obstructive sleep apnea. Mild = 2-4.9, Moderate = 5-9.9, Severe = 10 or more. | Posted | Median | Full Range | events per hour | Up to 10 hours |
|
|
Up to 10 hours
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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 | WatchPAT Intervention | Wearing the WatchPAT device simultaneously while receiving a clinically indicated sleep study (polysomnogram). WatchPAT Intervention: Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Sobremonte-King, MD | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.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 | Jun 1, 2017 | Mar 23, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Blinded to the subject's diagnosis
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Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour. |
| Up to 10 hours |
| Sleep Staging: Light and Deep | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Up to 10 hours |
| Oxygen Saturation | Amount of oxygen present in the subjects blood via pulse oximetry. | Up to 10 hours |
| Heart Rate | Documentation of the Subjects heart rate. | Up to 10 hours |
| Body Position | Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc. | Up to 10 hours |
| Sleep Time (Total) | The Total Sleep Duration time in minutes as recorded by the PSG. | Up to 10 hours |
| Sleep Staging: REM | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Up to 10 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) | Peripheral index from the device sensor as measured on the skin, similar to a pulse oximeter. Count of respiratory events that do not meet the criteria for apnea, but that cause a disturbance in sleep. | Posted | Median | Full Range | events per hour | Up to 10 hours |
|
|
|
| Secondary | Oxygen Desaturation Index (ODI) | Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour. | Posted | Median | Full Range | events per hour | Up to 10 hours |
|
|
|
| Secondary | Sleep Staging: Light and Deep | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Posted | Mean | Standard Deviation | minutes | Up to 10 hours |
|
|
|
| Secondary | Oxygen Saturation | Amount of oxygen present in the subjects blood via pulse oximetry. | Posted | Median | Full Range | percentage of O2 | Up to 10 hours |
|
|
|
| Secondary | Heart Rate | Documentation of the Subjects heart rate. | Posted | Median | Full Range | beats per minute | Up to 10 hours |
|
|
|
| Secondary | Body Position | Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc. | Posted | Median | Full Range | minutes | Up to 10 hours |
|
|
|
| Secondary | Sleep Time (Total) | The Total Sleep Duration time in minutes as recorded by the PSG. | Posted | Median | Full Range | minutes | Up to 10 hours |
|
|
|
| Secondary | Sleep Staging: REM | Overall sleep architecture parameters as reported on the Sleep Study PSG final report. Includes hyponogram that outlines the percentage of total sleep time spent in each stage of sleep (N1, N2, N3-4, and REM). | Posted | Median | Full Range | minutes | Up to 10 hours |
|
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| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
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| D020920 |
| Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |