Upper Airway Resistance SyndromeNCT00528749
Non-Invasive Measurement of Respiratory Effort
A study testing Patient will wear ARES device while undergoing sleep study in people with Upper Airway Resistance Syndrome, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
This study is intended to compare intrathoracic pressure and respiratory effort data obtained by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the current gold standard, esophageal manometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Airway Resistance Syndrome
- What is being tested?
- Patient will wear ARES device while undergoing sleep study
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to not given
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Age 18 or older,
- Referred for sleep study at WRAMC for suspected sleep disordered breathing.
Who cannot join
- Pregnancy
- Age <18
- Nasal defects precluding insertion of esophageal manometer
- Patients currently on anticoagulation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Christopher S King, MD, 202-782-5725, christopher.king@na.amedd.army.mil
About this study
This study is intended to compare intrathoracic pressure and respiratory effort data obtained by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the current gold standard, esophageal manometry. If this feasibility study validates the ability of FVP/RM data to quantitatively measure respiratory effort non-invasively, further studies will be performed to validate the utility of the ARES device in diagnosis of the UARS.
Read the detailed description
Sleep apnea is the most common disorder observed in the practice of sleep medicine and is responsible for more morbidity and mortality than any other sleep disorder.(1) Although characterized over 40 years ago, sleep apnea has only recently gained recognition as one of the world's most prevalent undiagnosed disorders. Due to associated morbidity and mortality, sleep apnea has been identified as a major public health concern. Currently, sleep apnea is diagnosed by performing a sleep study. This requires a patient staying overnight in a sleep laboratory while being monitored, which is often inconvenient for patients and is relatively expensive to perform. The development of a device that allows for simple home monitoring of patients when assessing for sleep apnea would be a significant development in the field of sleep medicine.
The differentiation of obstructive sleep apnea (OSA) from central sleep apnea is an important aspect of diagnosing and treating OSA. In central apneas/hyponeas, the lack of airflow is due to lack of respiratory effort. In OSA, effort to breathe continues, but airflow is prevented by an occluded airway. More recently, subtle obstructive events without a defined desaturation, characterized by increasing respiratory efforts against a partially closed airway and terminated by an arousal, have been described as Upper Airway Resistance Syndrome (UARS). UARS can lead to daytime somnolence due to these frequent arousals. Although nasal pressure signal has been used as a surrogate, by definition, distinguishing UARS from OSA requires the use of esophageal manometry. This syndrome is characterized by increased upper airway resistance (IUAR) that was defined by increasingly negative inspiratory esophageal pressure. (2) To better understand the clinical significance of esophageal manometry, let us briefly review some basic physiology. Taking a breath requires that the inspiratory muscles generate sufficient force to overcome the elastic recoil of the chest wall and lungs, frictional lung and chest wall tissue resistance, and the frictional resistance of airflow through the airways. At the end of inspiration, the potential energy stored in the tissues of the lungs and chest wall is available to allow rapid passive exhalation when the inspiratory muscles cease contraction and the distending force disappears. All intrathoracic structures are subjected to the pressures generated by breathing. The esophagus is a thin walled muscular tube that, from the view of pulmonary physiologists, is ideally placed in the thoracic cavity between the lung surface and the chest wall. Measurement of differential pressure changes in the lumen of the esophagus accurately reflect changes in intrathoracic pressure. These changes in intrathoracic pressure are in turn reflective of inspiratory effort and have become the gold standard for detecting and quantifying inspiratory effort.
Unfortunately, measurement of esophageal manometry requires the placement of an esophageal catheter via the nose or mouth. This procedure in invasive, time consuming, and requires specialized training. For this reason, esophageal manometry is not routinely performed during sleep studies, although it is performed in patients at the WRAMC sleep lab who are suspected of having UARS. Instead of esophageal manometry, the most frequently used method of monitoring respiratory effort is to record thoracic cage expansion. In this procedure, bands are placed around the rib cage and abdomen. The change in circumference of these two compartments with breathing is measured. This procedure yields a qualitative change in inspiratory volume and paradoxical movement of the rib cage or abdomen can indicate effort against a closed or partially collapsed airway. This device is impractical for self-application by patients. Given the limitations of the latter procedure and the invasive nature of esophageal manometry, a non-invasive quantitative method for measuring respiratory effort would be a significant advancement in sleep medicine.
Over the past five years, investigators from Advanced Brain Monitoring, Inc. developed and validated the Apnea Risk Evaluation System (ARES). This device was initially developed to provide a highly accurate method of in-home diagnosis of OSA that maximized patient comfort and ease of use. The ARES Unicorder was designed as a single site (forehead) system to acquire oxygen saturation, pulse rate, snoring, airflow (nasal pressure), and head position/movement. Recently, investigators determined that a number of signals that were being acquired with the Unicorder could be used to measure respiration.(1) Pulsations observed in the red and infrared optical signals used to compute oxygen saturation and the forehead sensor pressure signal appear to reflect central venous pressure changes. These data has been termed the Forehead Venous Pressure/Respiratory Movement (FVP/RM) measure. If FVP/RM data proves to correlate with esophageal manometry data, the long sought after non-invasive quantitative measurement of intrathoracic pressure and respiratory effort would be available. This would represent a significant advancement in the diagnostic evaluation of sleep disordered breathing.
To better illustrate how forehead venous pressure could reflect intrathoracic pressure, let us again review some physiology. During inspiration, the central venous pressure (CVP) decreases, aiding the return of blood to the heart. Changes in pleural and intrathoracic pressure due to respiration are reflected by and can be timed to changes in central venous pressure. When recumbent, the internal and external jugular veins are open and provide the primary cerebral and superficial forehead venous return. The communication between the superior vena cava and the veins of the headallows intrathoracic pressure changes to be reflected by the superficial veins of the head. In a sense, the forehead veins offer a direct fluid filled catheter into the thoracic cavity, and when the correct compressive force is applied against the skull, respiratory effort linked venous pressure changes can be accurately measured.
In summary, current evaluation of UARS requires esophageal manometry testing, an invasive and time consuming procedure for accurate diagnosis. Currently, no non-invasive quanitative means of measuring intrathoracic pressure changes linked to respiratory effort exists. This study is a pilot trial of a new non-invasive method of determining intrathoracic pressures. If intrathoracic pressure data from this device is found to correlate with esophgeal manometry data, this could have significant implications on the way in which UARS is diagnosed. This technology also has the potential to develop a non-invasive means of measuring CVP.
- Conditions
- Upper Airway Resistance Syndrome
- Being tested
- Patient will wear ARES device while undergoing sleep study
- Keywords
- Respiratory effort, Upper Airway Resistance Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient will wear ARES device while undergoing sleep studyOther
Device is worn on forehead
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of respiratory effort data generated by esophageal manometer with that generated by ARES device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Airway Resistance SyndromeStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Advanced Brain Monitoring, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528749
- Sponsor's protocol ID
- RespEffort
- Status last verified
- Aug 2007
- First submitted
- 11 Sep 2007
- Last updated
- 12 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Measurement of Respiratory Effort
- ClinicalTrials.gov ID
- NCT00528749
- Acronym / sponsor ID
- RespEffort
- Conditions
- Upper Airway Resistance Syndrome
- Keywords
- Respiratory effort, Upper Airway Resistance Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- Advanced Brain Monitoring, Inc.
- Study start
- Feb 2007
- First posted
- 12 Sep 2007 (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.
This study is intended to compare intrathoracic pressure and respiratory effort data obtained by forehead venous pressure and respiratory movement (FVP/RM) with data obtained by the current gold standard, esophageal manometry. If this feasibility study validates the ability of FVP/RM data to quantitatively measure respiratory effort non-invasively, further studies will be performed to validate the utility of the ARES device in diagnosis of the UARS.
Detailed description
Sleep apnea is the most common disorder observed in the practice of sleep medicine and is responsible for more morbidity and mortality than any other sleep disorder.(1) Although characterized over 40 years ago, sleep apnea has only recently gained recognition as one of the world's most prevalent undiagnosed disorders. Due to associated morbidity and mortality, sleep apnea has been identified as a major public health concern. Currently, sleep apnea is diagnosed by performing a sleep study. This requires a patient staying overnight in a sleep laboratory while being monitored, which is often inconvenient for patients and is relatively expensive to perform. The development of a device that allows for simple home monitoring of patients when assessing for sleep apnea would be a significant development in the field of sleep medicine.
The differentiation of obstructive sleep apnea (OSA) from central sleep apnea is an important aspect of diagnosing and treating OSA. In central apneas/hyponeas, the lack of airflow is due to lack of respiratory effort. In OSA, effort to breathe continues, but airflow is prevented by an occluded airway. More recently, subtle obstructive events without a defined desaturation, characterized by increasing respiratory efforts against a partially closed airway and terminated by an arousal, have been described as Upper Airway Resistance Syndrome (UARS). UARS can lead to daytime somnolence due to these frequent arousals. Although nasal pressure signal has been used as a surrogate, by definition, distinguishing UARS from OSA requires the use of esophageal manometry. This syndrome is characterized by increased upper airway resistance (IUAR) that was defined by increasingly negative inspiratory esophageal pressure. (2) To better understand the clinical significance of esophageal manometry, let us briefly review some basic physiology. Taking a breath requires that the inspiratory muscles generate sufficient force to overcome the elastic recoil of the chest wall and lungs, frictional lung and chest wall tissue resistance, and the frictional resistance of airflow through the airways. At the end of inspiration, the potential energy stored in the tissues of the lungs and chest wall is available to allow rapid passive exhalation when the inspiratory muscles cease contraction and the distending force disappears. All intrathoracic structures are subjected to the pressures generated by breathing. The esophagus is a thin walled muscular tube that, from the view of pulmonary physiologists, is ideally placed in the thoracic cavity between the lung surface and the chest wall. Measurement of differential pressure changes in the lumen of the esophagus accurately reflect changes in intrathoracic pressure. These changes in intrathoracic pressure are in turn reflective of inspiratory effort and have become the gold standard for detecting and quantifying inspiratory effort.
Unfortunately, measurement of esophageal manometry requires the placement of an esophageal catheter via the nose or mouth. This procedure in invasive, time consuming, and requires specialized training. For this reason, esophageal manometry is not routinely performed during sleep studies, although it is performed in patients at the WRAMC sleep lab who are suspected of having UARS. Instead of esophageal manometry, the most frequently used method of monitoring respiratory effort is to record thoracic cage expansion. In this procedure, bands are placed around the rib cage and abdomen. The change in circumference of these two compartments with breathing is measured. This procedure yields a qualitative change in inspiratory volume and paradoxical movement of the rib cage or abdomen can indicate effort against a closed or partially collapsed airway. This device is impractical for self-application by patients. Given the limitations of the latter procedure and the invasive nature of esophageal manometry, a non-invasive quantitative method for measuring respiratory effort would be a significant advancement in sleep medicine.
Over the past five years, investigators from Advanced Brain Monitoring, Inc. developed and validated the Apnea Risk Evaluation System (ARES). This device was initially developed to provide a highly accurate method of in-home diagnosis of OSA that maximized patient comfort and ease of use. The ARES Unicorder was designed as a single site (forehead) system to acquire oxygen saturation, pulse rate, snoring, airflow (nasal pressure), and head position/movement. Recently, investigators determined that a number of signals that were being acquired with the Unicorder could be used to measure respiration.(1) Pulsations observed in the red and infrared optical signals used to compute oxygen saturation and the forehead sensor pressure signal appear to reflect central venous pressure changes. These data has been termed the Forehead Venous Pressure/Respiratory Movement (FVP/RM) measure. If FVP/RM data proves to correlate with esophageal manometry data, the long sought after non-invasive quantitative measurement of intrathoracic pressure and respiratory effort would be available. This would represent a significant advancement in the diagnostic evaluation of sleep disordered breathing.
To better illustrate how forehead venous pressure could reflect intrathoracic pressure, let us again review some physiology. During inspiration, the central venous pressure (CVP) decreases, aiding the return of blood to the heart. Changes in pleural and intrathoracic pressure due to respiration are reflected by and can be timed to changes in central venous pressure. When recumbent, the internal and external jugular veins are open and provide the primary cerebral and superficial forehead venous return. The communication between the superior vena cava and the veins of the headallows intrathoracic pressure changes to be reflected by the superficial veins of the head. In a sense, the forehead veins offer a direct fluid filled catheter into the thoracic cavity, and when the correct compressive force is applied against the skull, respiratory effort linked venous pressure changes can be accurately measured.
In summary, current evaluation of UARS requires esophageal manometry testing, an invasive and time consuming procedure for accurate diagnosis. Currently, no non-invasive quanitative means of measuring intrathoracic pressure changes linked to respiratory effort exists. This study is a pilot trial of a new non-invasive method of determining intrathoracic pressures. If intrathoracic pressure data from this device is found to correlate with esophgeal manometry data, this could have significant implications on the way in which UARS is diagnosed. This technology also has the potential to develop a non-invasive means of measuring CVP.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older,
- Referred for sleep study at WRAMC for suspected sleep disordered breathing.
Key exclusion criteria (4 listed)
- Pregnancy
- Age <18
- Nasal defects precluding insertion of esophageal manometer
- Patients currently on anticoagulation
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 |
|---|---|---|
| Patient will wear ARES device while undergoing sleep studyDevice is worn on forehead | Other | – |
Primary outcome
Comparison of respiratory effort data generated by esophageal manometer with that generated by ARES device
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2007.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient will wear ARES device while undergoing sleep study in people with Upper Airway Resistance Syndrome, run by Walter Reed Army Medical Center 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 2 inclusion and 4 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 12 Sep 2007. 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 Christopher S King, MD (202-782-5725, christopher.king@na.amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of respiratory effort data generated by esophageal manometer with that generated by ARES device (time frame: 1 year). 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 12 Sep 2007.