Phase 3
N=10
PMP-300E (Smart Watch): Portable Monitoring Device Study
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01364740 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: AHI — 19.2; 19.3 events/hour — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PMP-300E (Device); In-lab PSG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AHI |
19.2; 19.3 | >0.05 |
| SECONDARY Apnea Index |
7.7; 9.8 | >0.05 |
| SECONDARY Hypopnea Index |
8.8; 14.1 | >0.05 |
| SECONDARY Oxygen Saturation |
94.8; 95.0 | >0.05 |
Summary
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
Eligibility Criteria
Inclusion Criteria:Inclusion Criteria:
- Age 18 and over.
- Require a sleep diagnostic study by physician's order.
- Able and willing to provide written informed consent.
- Able to speak and read English.
Exclusion Criteria:Exclusion Criteria:
- Participation in another interventional research study within the last 30 days.
- Unstable medical or psychiatric conditions that would interfere with the demands of the study or the ability to commit to follow-up assessment. Examples include unstable congestive heart failure, neuromuscular disease, cancer, and renal failure.
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake or participants qualifying for oxygen therapy (arterial saturation 88% for more than five minutes).
- Consumption of ethanol more than 4 nights per week. (CAGE criteria)
- Use of recreational drug within the past 12 months.
- Women who are pregnant or currently lactating.
Data sourced from ClinicalTrials.gov (NCT01364740). 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.