NCT05984186

Brief Summary

The study will evaluate the impact of high velocity therapy (HVT) on reduction of work of breathing (as implied by breath frequency) and enhanced blood lactate decline during recovery from a Wingate-type Exercise test. The study will include four study segments, corresponding to four different therapy settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 6, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

July 25, 2023

Results QC Date

August 20, 2024

Last Update Submit

September 12, 2024

Conditions

DyspneaLactic AcidosisMuscleBreathlessnessExerciseRecovery

Outcome Measures

Primary Outcomes (1)

  • Blood Lactate Change

    The change in blood lactate starting from the exercise test throughout the recovery period

    At rest (TR) and during recovery from the Wingate test at minute 2 (T2) minute 4 (T4), minute 6 (T6), minute 8 (T8), minute 10 (T10) minute 15 (T15), minute 20 (T20), minute 25 (T25), minute 30 (T30) minute 40 (T40), minute 50 (T50) minute 60 (T60).

Secondary Outcomes (6)

  • Respiratory Rate Change

    Prior to the Wingate test (TR) and after at 1min (T1), 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.

  • Heart Rate Change

    Prior to the Wingate test (TR) and after 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.

  • SpO2 Change

    Prior to the Wingate test (TR) and after at, 2min (T2), 4min (T4), 6min (T6), 8min (T8), 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.

  • Systolic Blood Pressure Change

    Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.

  • Diastolic Blood Pressure Change

    Prior to the Wingate test (TR) and after at, 5min (T5) 10min (T10), 15min (T15), 20min (T20), 25min (T25), 30min (T30), 40min (T40), 50 min (T50), and 60min (T60) into recovery.

  • +1 more secondary outcomes

Study Arms (4)

FiO2=100% with Flow=5LPM

EXPERIMENTAL

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Device: High Velocity Therapy

FiO2=21% with Flow=25-35LPM

EXPERIMENTAL

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Device: High Velocity Therapy

FiO2=100% with Flow=25-35LPM

EXPERIMENTAL

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Device: High Velocity Therapy

FiO2=21% with Flow=5LPM

EXPERIMENTAL

The study is a repeated measures model that will collect data on the participants with the designated HVT at four specified settings (Flow/FiO2) during the Wingate exercise test and during the recovery interval. The Wingate exercise test configuration, equipment and procedures will be repeated for each HVT setting for a matched dataset. The study will include four study arms, corresponding to four therapy settings being tested: (1) FiO2=100% with Flow=5LPM, (2) FiO2=21% with Flow=25-35LPM, (3) FiO2=100% with Flow=25-35LPM, (4) FiO2=21% with Flow=5LPM. The participants will wear the appropriately sized nasal cannula interface during the exercise and recovery.

Device: High Velocity Therapy

Interventions

High Velocity TherapyDEVICE

FiO2=100% with Flow=5LPM FiO2=21% with Flow=25-35LPM FiO2=100% with Flow=25-35LPM FiO2=21% with Flow=5LPM

FiO2=100% with Flow=25-35LPMFiO2=100% with Flow=5LPMFiO2=21% with Flow=25-35LPMFiO2=21% with Flow=5LPM

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults18-30 years old, in a general state of good health, of either sex
  • No known contraindication to performing a maximal exercise test, i.e., Wingate-type Anaerobic exercise test
  • Participants must consider themselves able to perform "regular moderate" or "regular strenuous" exercise.
  • ° "Regular moderate" exercise includes less than 30 minutes every day or 30 minutes every other day, of some form of deliberate exercise, that does not include walking.
  • ° "Regular strenuous" exercise is 30+ minutes per day, of some form of deliberate exercise, that does not include walking.

You may not qualify if:

  • Not considered a 'high-performance athlete'
  • Known active cardiovascular, metabolic, liver, or renal disease
  • Orthopedic limitations to exercise
  • Pregnancy
  • Use of beta-blockers or beta-agonist asthma medications
  • Exercise induced asthma
  • Any other health-related issue that would involve the participant's fitness capability
  • Inability to complete all of the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Conditions

DyspneaAcidosis, LacticMotor Activity

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Results Point of Contact

Title
Katherine Gerich
Organization
Vapotherm
kgerich@vtherm.com
5854696753

Study Officials

  • Bruce Gladden

    Auburn University

    PRINCIPAL INVESTIGATOR

  • Michael Roberts

    Auburn University

    PRINCIPAL INVESTIGATOR

  • Max Michael

    Auburn University

    PRINCIPAL INVESTIGATOR

  • Nina Stute

    Auburn University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 9, 2023

Study Start

March 6, 2023

Primary Completion

July 31, 2023

Study Completion

December 31, 2023

Last Updated

October 8, 2024

Results First Posted

October 8, 2024

Record last verified: 2024-09

Locations

US(1)