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Non-Invasive Measurement of Respiratory Effort

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Advanced Brain Monitoring, Inc.
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00528749
First received: September 11, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT00528749

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

Locations
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.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00528749     History of Changes
Other Study ID Numbers: RespEffort
Study First Received: September 11, 2007
Last Updated: September 11, 2007
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Respiratory effort
Upper Airway Resistance Syndrome

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014