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Non-Invasive Measurement of Respiratory Effort

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Walter Reed Army Medical Center.
Recruitment status was:  Recruiting
Advanced Brain Monitoring, Inc.
Information provided by:
Walter Reed Army Medical Center Identifier:
First received: September 11, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
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 Intervention
Upper Airway Resistance Syndrome
Other: Patient will wear ARES device while undergoing sleep study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Non-Invasive Measurement of Respiratory Effort

Further study details as provided by Walter Reed Army Medical Center:

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

Estimated Enrollment: 20
Study Start Date: February 2007
Intervention Details:
    Other: Patient will wear ARES device while undergoing sleep study
    Device is worn on forehead
  Show Detailed Description


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00528749

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army Medical Center
Advanced Brain Monitoring, Inc.
  More Information Identifier: NCT00528749     History of Changes
Other Study ID Numbers: RespEffort 
Study First Received: September 11, 2007
Last Updated: September 11, 2007

Keywords provided by Walter Reed Army Medical Center:
Respiratory effort
Upper Airway Resistance Syndrome processed this record on February 17, 2017