Suspended
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
What is being tested
Measurement of PPG waveforms
+ Measurement of Pulse Arrival Time (PAT)
Device
Who is being recruted
Apnea+6
+ Nervous System Diseases
+ Respiration Disorders
Over 21 Years
+6 Eligibility Criteria
How is the trial designed
Diagnostic Study
Interventional
Study Start: May 2013
Summary
Principal SponsorSotera Wireless, Inc.
Study ContactAnoop Karippot, M.D.More contacts
Last updated: April 15, 2013Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorSotera Wireless, Inc.
Study ContactAnoop Karippot, M.D.More contacts
Last updated: April 15, 2013Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea SyndromesSleep Apnea, Obstructive
Criteria
1 inclusion criteria required to participate
Patients twenty-one years of age or older
5 exclusion criteria prevent from participating
Inability to obtain a Sotera cuff pressure and/or PPG signals
Patient refusal to participate in study
Patients under 21 (twenty-one) years of age
Patients with cardiac dysrhythmia (arrhythmia), including atrial fibrillation, and frequent premature atrial and/or ventricular contractions
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalCollection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours
Group II
ExperimentalCollection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
SuspendedOne Study Center