Back to resultsAssessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Measurement of PPG waveforms
Measurement of Pulse Arrival Time (PAT)
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring sleep apnea
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
Sites / Locations
- Palomar Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Measurement of PPG waveforms
Measurement of Pulse Arrival Time (PAT)
Arm Description
Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01831583
Brief Title
Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sotera Wireless, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
sleep apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Measurement of PPG waveforms
Arm Type
Experimental
Arm Description
Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Arm Title
Measurement of Pulse Arrival Time (PAT)
Arm Type
Experimental
Arm Description
Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Intervention Type
Device
Intervention Name(s)
Measurement of PPG waveforms
Other Intervention Name(s)
ViSi Monitor
Intervention Description
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
Intervention Type
Device
Intervention Name(s)
Measurement of Pulse Arrival Time (PAT)
Other Intervention Name(s)
ViSi Monitor
Intervention Description
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
Primary Outcome Measure Information:
Title
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome.
Description
The goal of this study is to collect pulse arrival time data as a means for the assessment of upper airway obstruction.
Time Frame
4 - 8 hours
Secondary Outcome Measure Information:
Title
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
Description
The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction.
Time Frame
4 - 8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anoop Karippot, M.D.
Phone
(858) 412-7362
Email
karippot@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Welch, MS
Organizational Affiliation
Sotera Wireless
Official's Role
Study Director
Facility Information:
Facility Name
Palomar Hospital
City
Escondido
State/Province
California
ZIP/Postal Code
92029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anoop Karippot, M.D.
12. IPD Sharing Statement
Learn more about this trial
Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
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