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

Sleep Apnea, Obstructive Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01831583
• Other study ID #: 2013-01
• Status: Not yet recruiting
• Phase: N/A
• First received: March 25, 2013
• Last updated: April 9, 2013
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: April 2013
• Source: Sotera Wireless, Inc.
• Contact: Anoop Karippot, M.D.
• Phone: (858) 412-7362
• Email: karippot[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Airway Obstruction
• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Measurement of PPG waveforms
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
• Measurement of Pulse Arrival Time (PAT)
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.

Locations

Country	Name	City	State
United States	Palomar Hospital	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
Sotera Wireless, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	4 - 8 hours	No