Sleep Apnea, ObstructiveNCT01831583
Assessment of PPG & PAT to Detect Upper Airway Obstruction in Patients With Obstructive Sleep Apnea
A study testing Measurement of PPG waveforms and Measurement of Pulse Arrival Time (PAT) in people with Sleep Apnea, Obstructive, run by Sotera Wireless, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Measurement of PPG waveforms and Measurement of Pulse Arrival Time (PAT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients twenty-one years of age or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Palomar Hospital
Escondido, California, 92029
Anoop Karippot, M.D.
About this study
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
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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Measurement of PPG waveforms, Measurement of Pulse Arrival Time (PAT)
- Keywords
- sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of PPG waveformsDevice
Also called ViSi Monitor
The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
Measurement of Pulse Arrival Time (PAT)Device
Also called ViSi Monitor
The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Measurement of PPG waveforms | Experimental | Collection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours Receives: Device: Measurement of PPG waveforms |
| Measurement of Pulse Arrival Time (PAT) | Experimental | Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours Receives: Device: Measurement of Pulse Arrival Time (PAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 - 8 hours
Secondary outcomes (1)
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.
Measured: 4 - 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sotera Wireless, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Welch, MS, Study director, Sotera Wireless
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831583
- Sponsor's protocol ID
- 2013-01
- Status last verified
- Apr 2013
- First submitted
- 25 Mar 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01831583
- Acronym / sponsor ID
- 2013-01
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- sleep apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sotera Wireless, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measurement of PPG waveforms | Experimental | Device: Measurement of PPG waveformsCollection of photoplethysmograph(PPG)waveform data from patients with obstructive sleep apnea for 4-8 hours |
| Measurement of Pulse Arrival Time (PAT) | Experimental | Device: Measurement of Pulse Arrival Time (PAT)Collection of PAT waveform data from patients with obstructive sleep apnea for 4-8 hours |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients twenty-one years of age or older
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of PPG waveformsAlso: ViSi MonitorThe ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours. | Device | Measurement of PPG waveforms |
| Measurement of Pulse Arrival Time (PAT)Also: ViSi MonitorThe ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours. | Device | Measurement of Pulse Arrival Time (PAT) |
Primary outcome
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.
1 secondary outcome
Non-invasive Photoplethysmographic (PPG) measurement in patients with obstructive sleep apnea syndrome.
Time frame: 4 - 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Welch, MS study director
Sotera Wireless
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of PPG waveforms and Measurement of Pulse Arrival Time (PAT) in people with Sleep Apnea, Obstructive, run by Sotera Wireless, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Karippot, M.D. ((858) 412-7362, karippot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pulse arrival time in patients with obstructive sleep apnea syndrome. (time frame: 4 - 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.