Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 15, 2013
April 1, 2013
3 months
March 25, 2013
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.
The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction.
4 - 8 hours
Secondary Outcomes (1)
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
4 - 8 hours
Study Arms (2)
Measurement of PPG waveforms
EXPERIMENTALCollection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Measurement of Pulse Arrival Time (PAT)
EXPERIMENTALCollection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Interventions
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
Eligibility Criteria
You may qualify if:
- Patients twenty-one years of age or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Palomar Hospital
Escondido, California, 92029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Welch, MS
Sotera Wireless
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2013
First Posted
April 15, 2013
Study Start
May 1, 2013
Primary Completion
August 1, 2013
Study Completion
September 1, 2013
Last Updated
April 15, 2013
Record last verified: 2013-04