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

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ClinicalTrials.gov Identifier: NCT01831583
Recruitment Status : Unknown
Verified April 2013 by Sotera Wireless, Inc..
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
Sotera Wireless, Inc.

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Measurement of PPG waveforms Device: Measurement of Pulse Arrival Time (PAT) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : May 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Measurement of PPG waveforms
Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Device: Measurement of PPG waveforms
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
Other Name: ViSi Monitor

Experimental: Measurement of Pulse Arrival Time (PAT)
Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Device: Measurement of Pulse Arrival Time (PAT)
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
Other Name: ViSi Monitor




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome. [ Time Frame: 4 - 8 hours ]
    The goal of this study is to collect PPG waveforms as a means for the assessment of upper airway obstruction.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831583


Contacts
Contact: Anoop Karippot, M.D. (858) 412-7362 karippot@gmail.com

Locations
United States, California
Palomar Hospital Not yet recruiting
Escondido, California, United States, 92029
Principal Investigator: Anoop Karippot, M.D.         
Sponsors and Collaborators
Sotera Wireless, Inc.
Investigators
Study Director: James Welch, MS Sotera Wireless

Responsible Party: Sotera Wireless, Inc.
ClinicalTrials.gov Identifier: NCT01831583     History of Changes
Other Study ID Numbers: 2013-01
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by Sotera Wireless, Inc.:
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Airway Obstruction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Insufficiency