NCT06480071

Brief Summary

This study investigates the contribution of nasal breathing to the performance during aerobic and anaerobic heavy exercise in 12 male elite cyclists. In a ramp test on a mechanically braked cycle ergometer (Monark LT2, Varberg, Sweden) VO2 max, heart rate, respiratory frequency, intranasal geometry and nasal airflow resitance as well as blood lactate and glucose was measured at each step of the ramp test and after a maximum exhaust test. Nasal breathing was randomized to three sepratae tests, normal open nose, decongested nose with oxymetazoline 0.5mg/ml, 2 sprays each nostril and with a nose clip. The study showed that in the test with the nose clip, mean blood lactate was significantly lower.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 24, 2024

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • VO2 max

    maximum oxygen upptake during exrecise

    7 minutes per cycle

  • blood lactate

    lactic acid, a cmponent produced during anaerobic heavy exercise

    7 minutes per cycle

  • Effect

    Watt effect generated during exercise

    7 minutes per cycle

Secondary Outcomes (2)

  • HR

    7 minutes per cycle

  • nasal air flow resistance

    7 minutes per cycle

Study Arms (1)

Nasal decongestion during exercise

EXPERIMENTAL

Nasal decongestion with oxymetazomin nasal spray 0.05% 2 sprays each nostril 10 minutes before the exercise test

Drug: Oxymetazoline, 0.05% Nasal Spray

Interventions

2 sprays each nostril before the excercise test.

Nasal decongestion during exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsTo increase standardisation regarding physical performance only one sex was included in the study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male subjects
  • age 18-40
  • elite cyclists or Triathlon athletes
  • minimum VO2max of ≥65 ml/min/kg on pretest.

You may not qualify if:

  • non-male
  • \<18\>40 years of age
  • non-elite cyclists or Triathlon athletes
  • less than VO2max of ≥65 ml/min/kg on pretest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ENT Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Mouth Breathing

Interventions

OxymetazolineNasal Sprays

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAerosolsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Johan Hellgren, MD, PhD, Professor

    Department of ENT Sahlgrenska University Hospital Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The nasal mucosa was decongested with oxymetazoline nasal spray 0.5mg/ml 2 sprays eacg nostril to achieve maximum nasal decongestion and to investigate if this promotes the physical performance during heavey exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

January 13, 2022

Primary Completion

March 17, 2022

Study Completion

March 17, 2022

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations