NCT00528749

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
Last Updated

September 12, 2007

Status Verified

August 1, 2007

First QC Date

September 11, 2007

Last Update Submit

September 11, 2007

Conditions

Upper Airway Resistance Syndrome

Keywords

Respiratory effortUpper Airway Resistance Syndrome

Outcome Measures

Primary Outcomes (1)

  • Comparison of respiratory effort data generated by esophageal manometer with that generated by ARES device

    1 year

Interventions

Patient will wear ARES device while undergoing sleep studyOTHER

Device is worn on forehead

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

RECRUITING

Central Study Contacts

Christopher S King, MD

CONTACT

202-782-5725christopher.king@na.amedd.army.mil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

February 1, 2007

Last Updated

September 12, 2007

Record last verified: 2007-08

Locations

US(1)