PMP-300E (Smart Watch): Portable Monitoring Device Study

Stanford University

Status and phase: Completed; Phase 3

Conditions: Obstructive Sleep Apnea

Treatments: Device: PMP-300E; Device: In-lab PSG

Study type: Interventional

Funder types: Other

Identifiers

NCT01364740

K073327 (Registry Identifier)

SU-04212009-2358

eProtocol 13181 (Other Identifier)

SPO 42154 (Other Identifier)

Details and patient eligibility

About

Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.

Full description

The purpose of the study is to validate an Obstructive Sleep Apnea portable monitoring device, PMP-300E. Validating process compared data collected by PMP-300E with data collected from in-lab polysomnography.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

PMP-300E, In-Lab PSG

Experimental group

Description:

PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)

Treatment:

Device: In-lab PSG

Device: PMP-300E