NCT03188718: WPAT

WatchPAT Device Validation Study Compared to Polysomnography

Completed NA Results posted Last updated 21 April 2021

What this trial tests

NA trial testing WatchPAT Intervention in Sleep Apnea Syndromes in 45 participants. Completed in 1 June 2019.

Timeline

7 December 2017

Primary endpoint
1 June 2019

1 June 2019

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	45
Start date	7 December 2017
Primary completion	1 June 2019
Estimated completion	1 June 2019
Sites	1 location across United States

Drugs / interventions tested

• WatchPAT Intervention

Conditions studied

• Sleep Apnea Syndromes — all drugs for Sleep Apnea Syndromes →
• Sleep Disorder — all drugs for Sleep Disorder →
• Sleep — all drugs for Sleep →

Sponsor

University of Colorado, Denver

Who can join

Adults 4 to 12, any sex, with Sleep Apnea Syndromes or Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) Primary · 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.

Group	Value	95% CI
WatchPAT Intervention	13.3	3.1 – 63.4

Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) Secondary · 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.

Group	Value	95% CI
WatchPAT Intervention	18.3	7.5 – 93

Oxygen Desaturation Index (ODI) Secondary · Up to 10 hours

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

Group	Value	95% CI
WatchPAT Intervention	4.9	.3 – 43.3

Sleep Staging: Light and Deep Secondary · 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).

Light

Group	Value	95% CI
WatchPAT Intervention	180	± 48.5

Deep

Group	Value	95% CI
WatchPAT Intervention	108	± 35.3

Oxygen Saturation Secondary · Up to 10 hours

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

Group	Value	95% CI
WatchPAT Intervention	94	90 – 95

Heart Rate Secondary · Up to 10 hours

Documentation of the Subjects heart rate.

Group	Value	95% CI
WatchPAT Intervention	78	52 – 104

Body Position Secondary · Up to 10 hours

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

Supine

Group	Value	95% CI
WatchPAT Intervention	162	0 – 489

Non-supine

Group	Value	95% CI
WatchPAT Intervention	229	0 – 434

Sleep Time (Total) Secondary · Up to 10 hours

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

Group	Value	95% CI
WatchPAT Intervention	427	155 – 515

Sleep Staging: REM Secondary · 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).

Group	Value	95% CI
WatchPAT Intervention	93.5	27 – 276

Sponsor's own description

Validation study of a novel sleep Device compared to a traditional sleep study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.