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CompletedNCT07005622Updated Jun 5, 2025

Inspiratory Muscle Training Using the O2 Trainer

An interventional study of O2 Trainer and Deep breathing in Inspiratory Muscle Training and Blood Pressure, sponsored by Sam Houston State University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Sam Houston State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals.

02

Conditions studied

  • Inspiratory Muscle Training
  • Blood Pressure

Keywords

  • Maximal Respiratory Pressures
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18-65
  • Able to participate in training 5 days per week

Exclusion criteria

Exclusion Criteria:

  • Previous ventilation
  • Diagnosed chronic obstructive pulmonary disease (COPD)
  • Uncontrolled asthma
  • Previous ear drum rupture
  • Previous abdominal hernia
  • Acute respiratory infection
  • Currently pregnant
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Placebo comparator
    Control Group

    The control group will practice deep breathing exercise 5 times per week

    Other: Deep breathing

  • Experimental
    Experimental Group

    The experimental group will participate in inspiratory muscle training 5 times per week

    Other: O2 Trainer

Interventions

  • OtherO2 Trainer

    The O2 Trainer uses varying caps to limit airflow during inspiration.

  • OtherDeep breathing

    Comparator/placebo for the control group

05

What researchers measure

Primary outcomes

  1. Maximal Inspiratory Force

    Inspiratory force (mmHg) will be measured using a digital pressure gauge connected to a mouthpiece.

    Time frame: Change following 5-6 weeks of training

Secondary outcomes

  1. Blood Pressure

    mmHG measured by FDA approved automated blood pressure cuff.

    Time frame: Change following 5-6 weeks of training

  2. Resting Heart Rate

    Beats per minute, measured using a chest worn heart rate monitor.

    Time frame: Change following 5-6 weeks of training

  3. Heart Rate Variability

    Measured using a chest worn heart rate monitor.

    Time frame: Change following 5-6 weeks of training

  4. Diaphragm Thickness

    Measured by ultrasound

    Time frame: Change following 5-6 weeks of training

Other outcomes

  1. Handgrip strength via handgrip dynamometer

    Strength of handgrip will be recorded as kg of force using a handgrip dynamometer.

    Time frame: Change following 5-6 weeks of training

06

Study locations

1 site
  • Sam Houston State University College of Osteopathic Medicine
    Conroe, Texas 77304, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07005622
Lead sponsor
Sam Houston State University
Responsible party
Patrick Davis (Director of Research, Sam Houston State University) — Principal investigator
First posted
Jun 5, 2025
Start date
Mar 26, 2024
Primary completion
Jul 15, 2024
Completion
Aug 1, 2024
Last update
Jun 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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