Feel Breathe, Restriction Device Ventilatory Nasal

Study Overview
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Brief Summary
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It has patented a restriction and filtering device ventilatory nasal flow FeelBreathe with the aim of increase nasal airflow resistance, therefore the objective was to examine the effects of FeelBreathe with lung ventilation and gas exchange during exercise.

Detailed Description
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Background: Different devices are currently used to train inspiratory muscles, thus showing an increase in the physical performance. It is a control trial to investigate the effects of a new restriction and filtering device ventilatory nasal flow (FeelBreathe). Methods: A total of 27 trained male caucasian subjects (age: 32.5 ± 7.23 years) were recruited from different sports clubs. Measurement of maximum static inspiratory pressure were taken before exercise testing and an incremental test in cycle ergometer to volitional fatigue for the determination of gas exchange data. Each subject performed three identical submaximal exercises at 50% of ventilatory thresholds under different breathing conditions: 1) oronasal breathing 2) nasal breathing and 3) nasal breathing with Feel Breathe, Restriction and Filtering Device Ventilatory Nasal Flow. Discussion: Researchers try to find if the new device called FeelBreathe causes changes in the lung ventilation and gas exchange during exercise. If the results show altered breathing pattern and cardiometabolic variables, FeelBreathe could be used to training respiratory muscles.

Official Title
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Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise

Conditions
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Mouth Breathing, Restrictive Breathing Pattern

Intervention / Treatment
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* Device: Feel Breathe, restriction device ventilatory nasal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 25-35 years. trained male caucasian cyclists Non-smokers Each subject completed an approved informed consent form and detailed health questionnaire before testing. Exclusion Criteria: Smokers. Presence of diseases during the test period. In particular, they had no current symptoms of nasal disease, snoring, asthma or allergic rhinitis. Unwillingness to complete the study requirements.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclist group<br> | Device: Feel Breathe, restriction device ventilatory nasal<br>* The Feel Breathe (FB) consisted of a small adhesive strip that is placed across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacturer's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. Each subject was required to perform three identical submaximal exercises with intensity at 50% VT1-VT2 under different breathing conditions. The breathing conditions were: oronasal, nasal and FB breathing. All participants performed three trials of stable load (50% VT1-VT2) for 10 minutes in the three conditions mentioned above, setting the cadence at 70-75 rpm, and controlling the same in all three exercise conditions.<br>* Other names: Feel Breathe. Registro: N0299875-0.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists | VE (l/min), Vtin (ml/kg), BF (bf/min), VCO2 (ml/min), VE/VO2 (ml), VE/VCO2 (ml), RER (VCO2/VO2), PETO2 (mmHg), PETCO2 (mmHg), tin (s/insp), tex (s/expir), Vtin (ml/min), Vtex (ml/min), SPO2 (%) and VO2 (ml/kg/min) were assessed throughout the exercise on a cycle ergometer (ERGO-Line GmbH + CoKG, mod. Jaeger ER-900. Germany) using three different conditions of breathing: oronasal, nasal and nasal breathing with FeelBreathe, with 10-sec sampling intervals using a open circuit spirometry (CPX Cardinal Health, 234 GmbH, Leibnizstrasse 7, D-97204 Hoechberg, Germany). | Subjects were assessed during 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum oxygen uptake | Before experimental trials each subject performed a incremental protocol on a cycle ergometer (ERGO-Line GmbH + CoKG, mod. Jaeger ER-900. Alemania) for the determination of gas exchange. The test was stopped upon volitional fatigue of the subject gas-exchange data were measured breath-by-breath using open circuit spirometry (CPX Cardinal Health, 234 GmbH, Leibnizstrasse 7, D-97204 Hoechberg, Alemania). | Subjects were assessed during 8 weeks | 
| Maximum static inspiratory pressure (PImax) | Inspiratory muscle testing was performed using a mouth pressure meter (Micro Medical Inc., Chatham, Kent, UK). The manufacturer states that the test-retest reliability of this device is ±3%. Maximum static inspiratory pressure was measured at residual volume and the best result from three inspiratory attempts was taken. At least one minute was allowed between attempts to minimize the effects of muscle fatigue. | Subjects were assessed during 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Restriction device ventilatory nasal flow, oronasal breathing, nasal breathing.