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Clinical Trials/NCT01831583
NCT01831583
Unknown
Not Applicable

Assessment of a New Photoplethysmographic (PPG) Method and a Pulse Arrival Time Method to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in a Sleep Laboratory

Sotera Wireless, Inc.1 site in 1 country15 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
Sotera Wireless, Inc.
Enrollment
15
Locations
1
Primary Endpoint
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
September 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.

Time Frame: 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 Outcomes

  • Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.(4 - 8 hours)

Study Sites (1)

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