Feel Breathe, Restriction Device Ventilatory Nasal

NCT01608529 | Completed Phase 1

• 1 other identifier: AC26392
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mouth Breathing; Restrictive Breathing Pattern

Keywords

Restriction device ventilatory nasal flow; oronasal breathing; nasal breathing.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum oxygen uptake

  Subjects were assessed during 8 weeks

• Maximum static inspiratory pressure (PImax)

  Subjects were assessed during 8 weeks

Study Arms (1)

Cyclist group

EXPERIMENTAL

Device: Feel Breathe, restriction device ventilatory nasal

Interventions

Feel Breathe, restriction device ventilatory nasal DEVICE

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.

Also known as: Restriction device ventilatory nasal. PCT/ES2010/000429., Feel Breathe. Registro: N0299875-0.

Cyclist group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 25-35 years.
• trained male caucasian cyclists
• Non-smokers
• Each subject completed an approved informed consent form and detailed health questionnaire before testing.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Consejo Superior de Deportes, Spain: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

Centro de Medicina del Deporte

San Fernando, Cadiz, 11100, Spain

Location

MeSH Terms

Conditions

Mouth Breathing

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose Lopez Chicharro, MD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 31, 2012
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

ES (1)