NCT00962728

Brief Summary

The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with postural tachycardia syndrome.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2009Dec 2026

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
17.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

17.3 years

First QC Date

August 18, 2009

Last Update Submit

December 18, 2025

Conditions

Postural Tachycardia SyndromePostural Orthostatic Tachycardia Syndrome

Keywords

heart ratetachycardiaorthostatic intolerance

Outcome Measures

Primary Outcomes (1)

  • Magnitude of orthostatic heart rate increase on upright posture

    10 min

Secondary Outcomes (2)

  • Symptoms rating with upright posture

    10 min

  • Hemodynamic changes on upright posture

    10 min

Study Arms (2)

ITD breathing device

EXPERIMENTAL

Breathing through the Res-Q-Gard ITD device from Advanced Circulatory Systems Inc.

Device: Inspiratory Threshold Device (Res-Q-Gard ITD)

Sham Device

SHAM COMPARATOR

Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Device: Sham Inspiratory Threshold Device

Interventions

Inspiratory Threshold Device (Res-Q-Gard ITD)DEVICE

Patient will breathe through this device attached to a mouthpiece during assessment of orthostatic tolerance.

Also known as: Res-Q-Gard ITD device 7.0 (Ref:12-0463-000)
ITD breathing device
Sham Inspiratory Threshold DeviceDEVICE

Breathing through a respiratory particulate filter (Model 002850P, Sims Portex Inc, Keene NH) which will have minimal resistance.

Also known as: Model 002850P, Sims Portex Inc, Keene NH
Sham Device

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
  • Increase in heart rate ≥ 30 beats/min with position change from supine to standing (10 minutes)
  • Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence
  • Able and willing to provide informed consent

You may not qualify if:

  • Overt cause for postural tachycardia (such as acute dehydration)
  • Inability to give, or withdrawal of, informed consent
  • Pregnant
  • Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

  • Convertino VA, Ryan KL, Rickards CA, Cooke WH, Idris AH, Metzger A, Holcomb JB, Adams BD, Lurie KG. Inspiratory resistance maintains arterial pressure during central hypovolemia: implications for treatment of patients with severe hemorrhage. Crit Care Med. 2007 Apr;35(4):1145-52. doi: 10.1097/01.CCM.0000259464.83188.2C.

    PMID: 17334239BACKGROUND

  • Convertino VA, Ratliff DA, Crissey J, Doerr DF, Idris AH, Lurie KG. Effects of inspiratory impedance on hemodynamic responses to a squat-stand test in human volunteers: implications for treatment of orthostatic hypotension. Eur J Appl Physiol. 2005 Jul;94(4):392-9. doi: 10.1007/s00421-005-1344-1. Epub 2005 Apr 28.

    PMID: 15864634BACKGROUND

  • Gamboa A, Paranjape SY, Black BK, Arnold AC, Figueroa R, Okamoto LE, Nwazue VC, Diedrich A, Plummer WD, Dupont WD, Robertson D, Raj SR. Inspiratory resistance improves postural tachycardia: a randomized study. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):651-8. doi: 10.1161/CIRCEP.114.002605. Epub 2015 Mar 19.

    PMID: 25792354DERIVED

Related Links

MeSH Terms

Conditions

Postural Orthostatic Tachycardia SyndromeTachycardiaOrthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Satish R Raj, MD MSCI

    Vanderbilt University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Professor of Medicine

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 20, 2009

Study Start

July 1, 2009

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

US(1)