Sleep, Sleep Apnea Syndromes, Sleep Disorder
Conditions
Keywords
Polysomnogram, Sleep Disordered Breathing
Brief summary
Validation study of a novel sleep Device compared to a traditional sleep study.
Detailed description
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.
Interventions
DEVICEWatchPAT Intervention
Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.
Sponsors
Kaiser Permanente
Itamar-Medical, Israel
University of Colorado, Denver
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Blinded to the subject's diagnosis
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 5 through 12 years of age. 2. Referral to the Sleep Lab due to concerns for Obstructive Sleep Apnea (OSA) and presenting with symptoms such as: * snoring, * witnessed apneas, * daytime sleepiness, and * mouth breathing, etc. 3. Informed consent obtained.
Exclusion criteria
1. Medical conditions that can affect the tonometer reading such as: * peripheral vascular disease, * cyanotic heart disease, * systemic hypertension, and * sickle cell crisis. 2. Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as: * autism spectrum disorder, * Trisomy 21, and * neurodevelopmental disorders. 3. History of neuromuscular malformation 4. History of current supplemental oxygen use 5. History of current vasoactive, cardiac or seizure medication use 6. Inability or unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) | Up to 10 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index (ODI) | Up to 10 hours | Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour. |
| Sleep Staging: Light and Deep | Up to 10 hours | 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). |
| Oxygen Saturation | Up to 10 hours | Amount of oxygen present in the subjects blood via pulse oximetry. |
| Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) | Up to 10 hours | 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. |
| Body Position | Up to 10 hours | Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc. |
| Sleep Time (Total) | Up to 10 hours | The Total Sleep Duration time in minutes as recorded by the PSG. |
| Sleep Staging: REM | Up to 10 hours | 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). |
| Heart Rate | Up to 10 hours | Documentation of the Subjects heart rate. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device failure | 3 |
| Overall Study | Participant noncompliance | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | WatchPAT Intervention |
|---|---|
| Age, Categorical <=18 years | 37 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9 years STANDARD_DEVIATION 2.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
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.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) | 13.3 events per hour |
Secondary
Body Position
Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.
Time frame: Up to 10 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| WatchPAT Intervention | Body Position | Supine | 162 minutes |
| WatchPAT Intervention | Body Position | Non-supine | 229 minutes |
Secondary
Heart Rate
Documentation of the Subjects heart rate.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Heart Rate | 78 beats per minute |
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.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Oxygen Desaturation Index (ODI) | 4.9 events per hour |
Secondary
Oxygen Saturation
Amount of oxygen present in the subjects blood via pulse oximetry.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Oxygen Saturation | 94 percentage of O2 |
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.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) | 18.3 events per hour |
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).
Time frame: Up to 10 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| WatchPAT Intervention | Sleep Staging: Light and Deep | Light | 180 minutes | Standard Deviation 48.5 |
| WatchPAT Intervention | Sleep Staging: Light and Deep | Deep | 108 minutes | Standard Deviation 35.3 |
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).
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Sleep Staging: REM | 93.5 minutes |
Secondary
Sleep Time (Total)
The Total Sleep Duration time in minutes as recorded by the PSG.
Time frame: Up to 10 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| WatchPAT Intervention | Sleep Time (Total) | 427 minutes |