Feel Breathe, Restriction Device Ventilatory Nasal (FB)

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

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.

Study Overview

• Status: Completed
• Conditions: Mouth Breathing; Restrictive Breathing Pattern
• Intervention / Treatment: Device: Feel Breathe, restriction device ventilatory nasal

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Cadiz
    • San Fernando, Cadiz, Spain, 11100
      • Centro de Medicina del Deporte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cyclist group

Device: Feel Breathe, restriction device ventilatory nasal; 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.; Other Names: Restriction device ventilatory nasal. PCT/ES2010/000429.; Feel Breathe. Registro: N0299875-0.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cadiz
• Collaborators: European Regional Development Fund; Consejo Superior de Deportes
• Investigators: Principal Investigator: Jose Lopez Chicharro, MD, Universidad Complutense de Madrid; Study Chair: Jorge dR Fernandez Santos, Phd Student, University of Cádiz (Spain); Study Chair: Carmen Vaz Pardal, MD, Centro de Medicina del Deporte (Cádiz); Study Chair: Jose L Costa Sepulveda, Phd Student, University of Cádiz (Spain); Study Director: Jose L Gonzalez Montesinos, Phd, University of Cádiz (Spain); Study Director: Jose Castro Piñero, Phd, University of Cádiz (Spain); Study Director: Julio Conde Caveda, Phd, University of Cádiz (Spain)

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 17, 2012
• First Submitted That Met QC Criteria: May 26, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): May 17, 2013
• Last Update Submitted That Met QC Criteria: May 16, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Restriction device ventilatory nasal flow; oronasal breathing; nasal breathing.
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Mouth Breathing
• Other Study ID Numbers: AC26392