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Non-Invasive Measurement of Respiratory Effort

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ClinicalTrials.gov Identifier: NCT00528749
Recruitment Status : Unknown
Verified August 2007 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
First Posted : September 12, 2007
Last Update Posted : September 12, 2007
Sponsor:
Collaborator:
Advanced Brain Monitoring, Inc.
Information provided by:
Walter Reed Army Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Upper Airway Resistance Syndrome Other: Patient will wear ARES device while undergoing sleep study Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Non-Invasive Measurement of Respiratory Effort
Study Start Date : February 2007

Intervention Details:
  • Other: Patient will wear ARES device while undergoing sleep study
    Device is worn on forehead


Primary Outcome Measures :
  1. Comparison of respiratory effort data generated by esophageal manometer with that generated by ARES device [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Age 18 or older,
  • Referred for sleep study at WRAMC for suspected sleep disordered breathing.

Exclusion Criteria:

  • Pregnancy
  • Age <18
  • Nasal defects precluding insertion of esophageal manometer
  • Patients currently on anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528749


Contacts
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Contact: Christopher S King, MD 202-782-5725 christopher.king@na.amedd.army.mil

Locations
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United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Christopher S King, MD    202-782-5725    christopher.king@na.amedd.army.mil   
Sponsors and Collaborators
Walter Reed Army Medical Center
Advanced Brain Monitoring, Inc.
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ClinicalTrials.gov Identifier: NCT00528749    
Other Study ID Numbers: RespEffort
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: September 12, 2007
Last Verified: August 2007
Keywords provided by Walter Reed Army Medical Center:
Respiratory effort
Upper Airway Resistance Syndrome
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes