Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea

Sotera Wireless

Status: Unknown

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Measurement of PPG waveforms; Device: Measurement of Pulse Arrival Time (PAT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01831583

2013-01

Details and patient eligibility

About

The goal of this study is to collect raw waveform data for two separate noninvasive methods, both of which may be useful for the assessment of upper airway obstruction.

Enrollment: 15 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients twenty-one years of age or older

Exclusion criteria

• Patient refusal to participate in study
• Patients under 21 (twenty-one) years of age,
• Referring physician's refusal to have his/her patient participate in the study.
• Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions.
• Inability to obtain a Sotera cuff pressure and/or PPG signals

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Measurement of PPG waveforms

Experimental group

Description:

Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours

Treatment:

Device: Measurement of PPG waveforms

Measurement of Pulse Arrival Time (PAT)

Experimental group

Description:

Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours

Treatment:

Device: Measurement of Pulse Arrival Time (PAT)