N/A
Completed N=45
WatchPAT Device Validation Study Compared to Polysomnography
Sleep Apnea Syndromes · Sleep Disorders, Intrinsic · Sleep
Source: ClinicalTrials.gov NCT03188718 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) — 13.3 events per hour
Summary
Validation study of a novel sleep Device compared to a traditional sleep study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Arterial Tone Apnea-hypopnea Index (PAHI) |
13.3 | — |
| SECONDARY Peripheral Arterial Tone Respiratory Disturbance Index (PRDI) |
18.3 | — |
| SECONDARY Oxygen Desaturation Index (ODI) |
4.9 | — |
| SECONDARY Sleep Staging: Light and Deep |
180; 108 | — |
| SECONDARY Oxygen Saturation |
94 | — |
| SECONDARY Heart Rate |
78 | — |
| SECONDARY Body Position |
162; 229 | — |
| SECONDARY Sleep Time (Total) |
427 | — |
| SECONDARY Sleep Staging: REM |
93.5 | — |
Eligibility Criteria
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:
- snoring,
- witnessed apneas,
- daytime sleepiness, and
- mouth breathing, etc.
- Informed consent obtained.
Exclusion Criteria
- Medical conditions that can affect the tonometer reading such as:
- peripheral vascular disease,
- cyanotic heart disease,
- systemic hypertension, and
- sickle cell crisis.
- Medical conditions that can potentially limit tolerance of the WatchPAT 200 device such as:
- autism spectrum disorder,
- Trisomy 21, and
- neurodevelopmental disorders.
- 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
Data sourced from ClinicalTrials.gov (NCT03188718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.