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

Not Applicable

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Measurement of PPG waveforms; Device: Measurement of Pulse Arrival Time (PAT)

• Registration Number: NCT01831583
• Lead Sponsor: Sotera Wireless, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-25
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-15
• Last Update Posted: 2013-04-15
• Study Start: 2013-05
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of PPG waveforms	Measurement of PPG waveforms	Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Measurement of Pulse Arrival Time (PAT)	Measurement of Pulse Arrival Time (PAT)	Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours

Primary Outcome Measures

Name	Time	Method
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.	4 - 8 hours	The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction.

Secondary Outcome Measures

Name	Time	Method
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.	4 - 8 hours	The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction.

Trial Locations

Locations (1)

Palomar Hospital; 🇺🇸 Escondido, California, United States