Inspiratory Muscle TrainingNCT07005622
Inspiratory Muscle Training Using the O2 Trainer
A study testing O2 Trainer and Deep breathing in people with Inspiratory Muscle Training and Blood Pressure, run by Sam Houston State University at 1 site in United States.
Trial summary
This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inspiratory Muscle Training, Blood Pressure
- What is being tested?
- O2 Trainer and Deep breathing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Able to participate in training 5 days per week
Who cannot join
- Previous ventilation
- Diagnosed chronic obstructive pulmonary disease (COPD)
- Uncontrolled asthma
- Previous ear drum rupture
- Previous abdominal hernia
- Acute respiratory infection
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Sam Houston State University College of Osteopathic Medicine
Conroe, Texas, 77304
About this study
This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals.
- Conditions
- Inspiratory Muscle Training, Blood Pressure
- Being tested
- O2 Trainer, Deep breathing
- Keywords
- Maximal Respiratory Pressures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2 TrainerOther
The O2 Trainer uses varying caps to limit airflow during inspiration.
Deep breathingOther
Comparator/placebo for the control group
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | The control group will practice deep breathing exercise 5 times per week Receives: Other: Deep breathing |
| Experimental Group | Experimental | The experimental group will participate in inspiratory muscle training 5 times per week Receives: Other: O2 Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Force
Inspiratory force (mmHg) will be measured using a digital pressure gauge connected to a mouthpiece.
Measured: Change following 5-6 weeks of training
Secondary outcomes (4)
Blood Pressure
mmHG measured by FDA approved automated blood pressure cuff.
Measured: Change following 5-6 weeks of training
Resting Heart Rate
Beats per minute, measured using a chest worn heart rate monitor.
Measured: Change following 5-6 weeks of training
Heart Rate Variability
Measured using a chest worn heart rate monitor.
Measured: Change following 5-6 weeks of training
Diaphragm Thickness
Measured by ultrasound
Measured: Change following 5-6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start26 Mar 2024
- Primary completion15 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inspiratory Muscle TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sam Houston State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Davis, Sam Houston State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005622
- Sponsor's protocol ID
- IRB-2024-116
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Using the O2 Trainer
- ClinicalTrials.gov ID
- NCT07005622
- Acronym / sponsor ID
- IRB-2024-116
- Conditions
- Inspiratory Muscle Training, Blood Pressure
- Keywords
- Maximal Respiratory Pressures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sam Houston State UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of resistive inspiratory training using the O2 Trainer on cardiopulmonary outcomes in healthy individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Deep breathingThe control group will practice deep breathing exercise 5 times per week |
| Experimental Group | Experimental | Other: O2 TrainerThe experimental group will participate in inspiratory muscle training 5 times per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Able to participate in training 5 days per week
Key exclusion criteria (7 listed)
- Previous ventilation
- Diagnosed chronic obstructive pulmonary disease (COPD)
- Uncontrolled asthma
- Previous ear drum rupture
- Previous abdominal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O2 TrainerThe O2 Trainer uses varying caps to limit airflow during inspiration. | Other | Experimental Group |
| Deep breathingComparator/placebo for the control group | Other | Control Group |
Primary outcome
Maximal Inspiratory Force
Time frame: Change following 5-6 weeks of training
Inspiratory force (mmHg) will be measured using a digital pressure gauge connected to a mouthpiece.
4 secondary outcomes
Blood Pressure
Time frame: Change following 5-6 weeks of training
Resting Heart Rate
Time frame: Change following 5-6 weeks of training
Heart Rate Variability
Time frame: Change following 5-6 weeks of training
Diaphragm Thickness
Time frame: Change following 5-6 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2 Trainer and Deep breathing in people with Inspiratory Muscle Training and Blood Pressure, run by Sam Houston State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Force (time frame: Change following 5-6 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.