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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01831583
Enrollment
15
Registered
2013-04-15
Start date
2013-05-31
Completion date
2013-09-30
Last updated
2013-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apnea

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.

Interventions

DEVICEMeasurement of PPG waveforms

The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.

DEVICEMeasurement of Pulse Arrival Time (PAT)

The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.

Sponsors

Sotera Wireless, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

Primary ContactAnoop Karippot, M.D.
karippot@gmail.com(858) 412-7362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026