Feel Breathe, Restriction Device Ventilatory Nasal (FB)

University of Cadiz

Status and phase: Completed; Phase 1

Conditions: Restrictive Breathing Pattern; Mouth Breathing

Treatments: Device: Feel Breathe, restriction device ventilatory nasal

Study type: Interventional

Funder types: Other

Identifiers

NCT01608529

AC26392

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: Male

Ages: 25 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Cyclist group

Experimental group

Treatment:

Device: Feel Breathe, restriction device ventilatory nasal