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Trial Outcomes & Findings for WatchPAT Device Validation Study Compared to Polysomnography (NCT NCT03188718)

NCT ID: NCT03188718

Last Updated: 2021-04-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Up to 10 hours

Results posted on

2021-04-21

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
45
Overall Study
COMPLETED
37
Overall Study
NOT COMPLETED
8

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Participant noncompliance
4
Overall Study
Withdrawal by Subject
1
Overall Study
Device failure
3

Baseline Characteristics

WatchPAT Device Validation Study Compared to Polysomnography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
WatchPAT Intervention
n=37 Participants
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.
Age, Categorical
<=18 years
37 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
9 years
STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
7 Participants
n=5 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
11 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
37 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Peripheral Arterial Tone Apnea-hypopnea Index (PAHI)
13.3 events per hour
Interval 3.1 to 63.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Peripheral Arterial Tone Respiratory Disturbance Index (PRDI)
18.3 events per hour
Interval 7.5 to 93.0

SECONDARY outcome

Timeframe: Up to 10 hours

Peripheral index from the device sensor similar to a pulse oximeter. Number of desaturations by 3 percent in 1 hour.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Oxygen Desaturation Index (ODI)
4.9 events per hour
Interval 0.3 to 43.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Sleep Staging: Light and Deep
Light
180 minutes
Standard Deviation 48.5
Sleep Staging: Light and Deep
Deep
108 minutes
Standard Deviation 35.3

SECONDARY outcome

Timeframe: Up to 10 hours

Amount of oxygen present in the subjects blood via pulse oximetry.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Oxygen Saturation
94 percentage of O2
Interval 90.0 to 95.0

SECONDARY outcome

Timeframe: Up to 10 hours

Documentation of the Subjects heart rate.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Heart Rate
78 beats per minute
Interval 52.0 to 104.0

SECONDARY outcome

Timeframe: Up to 10 hours

Body position of sleeping subject to reflect upon overall sleep hygiene such as prone, supine, back, stomach, etc.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Body Position
Supine
162 minutes
Interval 0.0 to 489.0
Body Position
Non-supine
229 minutes
Interval 0.0 to 434.0

SECONDARY outcome

Timeframe: Up to 10 hours

The Total Sleep Duration time in minutes as recorded by the PSG.

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Sleep Time (Total)
427 minutes
Interval 155.0 to 515.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
WatchPAT Intervention
n=37 Participants
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.
Sleep Staging: REM
93.5 minutes
Interval 27.0 to 276.0

Adverse Events

WatchPAT Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Sobremonte-King, MD

University of Colorado Denver

Phone: 3037241111

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place