Sleep Apnea, ObstructiveNCT04443582
Point-of-care-Ultrasound for Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Rakesh Sondekoppam Vijayashankar at 1 site in United States.
Trial summary
Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the perioperative environment. The study is designed to evaluate if point-of-care-ultrasound (POCUS) measurements of upper airway anatomy may identify patients with OSA and their severity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 31 Dec 2021
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for surgeries who meet eligibility criteria.
Who may be able to join
- Patients of either gender
- Age 18 through 85
- History of previous sleep study polysomnography (PSG)
Who cannot join
- No prior sleep study
- History of central sleep apnea
- Craniofacial/oropharyngeal malformations
- Oropharyngeal surgery since the last sleep study
- Ear/Nose/Throat tumor
- History of Ear/Nose/Throat surgery
- Inability to consent
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of Correlating Point Of Care Ultrasound (POCUS) Measures of Sleep Apnea With STOP-BANG Scoring and Apnea-Hypopnea Index (AHI)
Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the perioperative environment. The study is designed to evaluate if point-of-care-ultrasound (POCUS) measurements of upper airway anatomy may identify patients with OSA and their severity.
Read the detailed description
Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous disorder with potentially multiple contributing pathophysiological causes but with significant impact to perioperative morbidity. Various OSA phenotypes exist but, the predominant feature is a narrow and collapsible upper airway anatomy and is an interplay between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is crucial to prevent potential life-threatening cardiopulmonary complications perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at the time of surgery.(2) Current screening tools are mainly questionnaire based and are largely sensitive but not specific (3) resulting in many false positives, unnecessary increased resource utilization, cost burden, and legal implications. Gold standard laboratory polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound (POCUS) is a readily available, portable, noninvasive tool that has been used for airway evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the various POCUS measures of OSA in the perioperative population and correlate these measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find out the best measure or a combination of measures to diagnose the incidence and severity of OSA.
- Conditions
- Sleep Apnea, Obstructive
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of POCUS measurements with AHI and/or STOP-Bang Scores
The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation.
STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start10 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rakesh Sondekoppam Vijayashankar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rakesh Sondekoppam Vijayashankar, University of Iowa
- Investigators
- Rakesh V. Sondekoppam, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443582
- Sponsor's protocol ID
- 202001068
- Status last verified
- Feb 2022
- First submitted
- 19 Jun 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Memtsoudis SG, Stundner O, Rasul R, Chiu YL, Sun X, Ramachandran SK, Kaw R, Fleischut P, Mazumdar M. The impact of sleep apnea on postoperative utilization of resources and adverse outcomes. Anesth Analg. 2014 Feb;118(2):407-418. doi: 10.1213/ANE.0000000000000051.
PubMed 24445639Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.
PubMed 23257990Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015.
PubMed 26658438Chen JW, Chang CH, Wang SJ, Chang YT, Huang CC. Submental ultrasound measurement of dynamic tongue base thickness in patients with obstructive sleep apnea. Ultrasound Med Biol. 2014 Nov;40(11):2590-8. doi: 10.1016/j.ultrasmedbio.2014.06.019. Epub 2014 Sep 12.
PubMed 25220277Lahav Y, Rosenzweig E, Heyman Z, Doljansky J, Green A, Dagan Y. Tongue base ultrasound: a diagnostic tool for predicting obstructive sleep apnea. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):179-84. doi: 10.1177/000348940911800304.
PubMed 19374148Liu KH, Chu WC, To KW, Ko FW, Tong MW, Chan JW, Hui DS. Sonographic measurement of lateral parapharyngeal wall thickness in patients with obstructive sleep apnea. Sleep. 2007 Nov;30(11):1503-8. doi: 10.1093/sleep/30.11.1503.
PubMed 18041482Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
PubMed 23675433Siegel H, Sonies BC, Graham B, McCutchen C, Hunter K, Vega-Bermudez F, Sato S. Obstructive sleep apnea: A study by simultaneous polysomnography and ultrasonic imaging. Neurology. 2000 May 9;54(9):1872. doi: 10.1212/wnl.54.9.1872. No abstract available.
PubMed 10802805
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Correlating Point Of Care Ultrasound (POCUS) Measures of Sleep Apnea With STOP-BANG Scoring and Apnea-Hypopnea Index (AHI)
- ClinicalTrials.gov ID
- NCT04443582
- Acronym / sponsor ID
- 202001068
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Rakesh Sondekoppam VijayashankarUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Jun 2020 (actual)
- 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.
Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the perioperative environment. The study is designed to evaluate if point-of-care-ultrasound (POCUS) measurements of upper airway anatomy may identify patients with OSA and their severity.
Detailed description
Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous disorder with potentially multiple contributing pathophysiological causes but with significant impact to perioperative morbidity. Various OSA phenotypes exist but, the predominant feature is a narrow and collapsible upper airway anatomy and is an interplay between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is crucial to prevent potential life-threatening cardiopulmonary complications perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at the time of surgery.(2) Current screening tools are mainly questionnaire based and are largely sensitive but not specific (3) resulting in many false positives, unnecessary increased resource utilization, cost burden, and legal implications. Gold standard laboratory polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound (POCUS) is a readily available, portable, noninvasive tool that has been used for airway evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the various POCUS measures of OSA in the perioperative population and correlate these measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find out the best measure or a combination of measures to diagnose the incidence and severity of OSA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for surgeries who meet eligibility criteria.
Key inclusion criteria (3 listed)
- Patients of either gender
- Age 18 through 85
- History of previous sleep study polysomnography (PSG)
Key exclusion criteria (8 listed)
- No prior sleep study
- History of central sleep apnea
- Craniofacial/oropharyngeal malformations
- Oropharyngeal surgery since the last sleep study
- Ear/Nose/Throat tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of POCUS measurements with AHI and/or STOP-Bang Scores
Time frame: 1 day
The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation. STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Background: PubMed 24445639Memtsoudis SG, Stundner O, Rasul R, Chiu YL, Sun X, Ramachandran SK, Kaw R, Fleischut P, Mazumdar M. The impact of sleep apnea on postoperative utilization of resources and adverse outcomes. Anesth Analg. 2014 Feb;118(2):407-418. doi: 10.1213/ANE.0000000000000051.
- Background: PubMed 23257990Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19.
- Background: PubMed 26658438Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015.
- Background: PubMed 25220277Chen JW, Chang CH, Wang SJ, Chang YT, Huang CC. Submental ultrasound measurement of dynamic tongue base thickness in patients with obstructive sleep apnea. Ultrasound Med Biol. 2014 Nov;40(11):2590-8. doi: 10.1016/j.ultrasmedbio.2014.06.019. Epub 2014 Sep 12.
- Background: PubMed 19374148Lahav Y, Rosenzweig E, Heyman Z, Doljansky J, Green A, Dagan Y. Tongue base ultrasound: a diagnostic tool for predicting obstructive sleep apnea. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):179-84. doi: 10.1177/000348940911800304.
- Background: PubMed 18041482Liu KH, Chu WC, To KW, Ko FW, Tong MW, Chan JW, Hui DS. Sonographic measurement of lateral parapharyngeal wall thickness in patients with obstructive sleep apnea. Sleep. 2007 Nov;30(11):1503-8. doi: 10.1093/sleep/30.11.1503.
- Background: PubMed 23675433Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
- Background: PubMed 10802805Siegel H, Sonies BC, Graham B, McCutchen C, Hunter K, Vega-Bermudez F, Sato S. Obstructive sleep apnea: A study by simultaneous polysomnography and ultrasonic imaging. Neurology. 2000 May 9;54(9):1872. doi: 10.1212/wnl.54.9.1872. No abstract available.
- Individual participant dataSharing planned: No
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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.
Rakesh V. Sondekoppam, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by Rakesh Sondekoppam Vijayashankar 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 28 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of POCUS measurements with AHI and/or STOP-Bang Scores (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443582, which also lists 8 linked publications.
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 28 Feb 2022.