CompletedNot Applicable

Effect of High Velocity/Hyperoxic Breathing Therapy on Blood Lactate Decline

United States15 participantsStarted 2023-03-06

Plain-language 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.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood Lactate Change

Timeframe: 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).

Trial details

NCT IDNCT05984186

SponsorVapotherm, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-31

Results submitted2024-08-20

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