Heat-exchanger breathing masks during heavy exertion in cold conditions; protection or a hindrance?

In healthy subjects, do heat and moisture exchange mask attenuate airway effects of physical activity in subzero temperature?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10018222

Enrollment

Registered

2019-04-01

Start date

2019-01-01

Completion date

Unknown

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway injury Respiratory

Interventions

Current interventions as of 20/06/2019: All participants will complete two standardized 45-minutes exercises in an environmental chamber with a temperature of - 15 degrees Celsius, one exercise with a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 20/06/2019: 1. Healthy, well-trained adults 2. Experience of treadmill running Previous inclusion criteria: 1. Healthy, competitive cross-country skier 2. > 3 years training experience and should be experienced in treadmill roller-skiing using the classical diagonal stride technique

Exclusion criteria

Exclusion criteria: 1. No reported airway infection within 4 weeks prior to each visit 2. Asthma, lung diseases and other diseases that may significantly affect their physical performance status

Design outcomes

Primary

Measure	Time frame
Delta-FEV1 (forced expiratory volume first second), measured by dynamic spirometry. Delta-FEV1 is FEV1 immediately post exposure minus FEV1 pre exposure. Delta-FEV1 with HME compared to delta-FEV1 without HME.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 01/11/2024: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16 and interleukins, not yet specified) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Heart rate and breathing rate measured during exposures 6. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA) 7. Performance will be defined as distance covered by a 4 minutes long sprint of running 8. Urinary LTE4 and 11ß-PGF2a pre and 60 min post exposure _____ Previous secondary outcome measures as of 20/06/2019: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16 and interleukins, not yet specified) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Heart rate and breathing rate measured during exposures 6. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA) 7. Performance will be defined as distance covered by a 4 minutes long sprint of running _____ Previous secondary outcome measures: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16, 8-isoprostane, IL-1ß, IL-6, and TNF-a) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Particles in exhaled breath using PExA instrument, pre and immediately post exposures 6. Heart rate and breathing rate measured during exposures 7	—

Measure

Time frame

Current secondary outcome measures as of 01/11/2024: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16 and interleukins, not yet specified) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Heart rate and breathing rate measured during exposures 6. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA) 7. Performance will be defined as distance covered by a 4 minutes long sprint of running 8. Urinary LTE4 and 11ß-PGF2a pre and 60 min post exposure _____ Previous secondary outcome measures as of 20/06/2019: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16 and interleukins, not yet specified) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Heart rate and breathing rate measured during exposures 6. Muscle oxygenation measured during exposures using (MOXY muscle oxygen monitor, Fortiori design LLC, Minnesota, USA) 7. Performance will be defined as distance covered by a 4 minutes long sprint of running _____ Previous secondary outcome measures: 1. Delta airway resistance (immediately post - pre exposure) using impulse oscillometry 2. Airway symptoms using questionnaires, pre, during, and post exposures 3. Biochemical markers of airway damage (CC-16, 8-isoprostane, IL-1ß, IL-6, and TNF-a) measured in blood samples pre and 60 minutes post exposures 4. Urine CC-16 measured pre and 60 minutes post exposures 5. Particles in exhaled breath using PExA instrument, pre and immediately post exposures 6. Heart rate and breathing rate measured during exposures 7

—

Countries

Sweden

Contacts

Public ContactNikolai Stenfors

nikolai.stenfors@umu.se+46 63153000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026