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

NCT ID: NCT01831583

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

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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

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Measurement of PPG waveforms

Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours

Group Type EXPERIMENTAL

Measurement of PPG waveforms

Intervention Type DEVICE

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

Measurement of Pulse Arrival Time (PAT)

Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours

Group Type EXPERIMENTAL

Measurement of Pulse Arrival Time (PAT)

Intervention Type DEVICE

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

Interventions

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Measurement of PPG waveforms

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

Intervention Type DEVICE

Measurement of Pulse Arrival Time (PAT)

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

Intervention Type DEVICE

Other Intervention Names

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ViSi Monitor ViSi Monitor

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sotera Wireless, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Welch, MS

Role: STUDY_DIRECTOR

Sotera Wireless

Locations

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Palomar Hospital

Escondido, California, United States

Site Status

Countries

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United States

Central Contacts

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Anoop Karippot, M.D.

Role: CONTACT

(858) 412-7362

Other Identifiers

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2013-01

Identifier Type: -

Identifier Source: org_study_id

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