Feel Breathe, Restriction Device Ventilatory Nasal (FB)

This study has been completed.
Sponsor:
Collaborators:
Universidad de Cádiz
Consejo Superior de Deportes
Fondo Europeo de Desarrollo Regional
Information provided by (Responsible Party):
University of Cadiz
ClinicalTrials.gov Identifier:
NCT01608529
First received: May 17, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Mouth Breathing
Restrictive Breathing Pattern
Device: Feel Breathe, restriction device ventilatory nasal
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1: Effects of a Restriction Device Ventilatory Nasal Flow on Pulmonary Ventilation and Gas Exchange During Exercise

Resource links provided by NLM:


Further study details as provided by University of Cadiz:

Primary Outcome Measures:
  • Overall Impact of a restriction device ventilatory nasal over different physiological variables in cyclists [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Maximum oxygen uptake [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]
    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).

  • Maximum static inspiratory pressure (PImax) [ Time Frame: Subjects were assessed during 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01608529

Locations
Spain
Centro de Medicina del Deporte
San Fernando, Cadiz, Spain, 11100
Sponsors and Collaborators
University of Cadiz
Universidad de Cádiz
Consejo Superior de Deportes
Fondo Europeo de Desarrollo Regional
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: Davinia Vicente Campos, Phd Universidad Complutense de Madrid
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)
  More Information

No publications provided

Responsible Party: University of Cadiz
ClinicalTrials.gov Identifier: NCT01608529     History of Changes
Other Study ID Numbers: AC26392
Study First Received: May 17, 2012
Last Updated: May 16, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by University of Cadiz:
Restriction device ventilatory nasal flow
oronasal breathing
nasal breathing.

Additional relevant MeSH terms:
Respiratory Aspiration
Mouth Breathing
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014