Impact of Masks on Oxygen LevelsMERITNCT04932226
Face Masks and Oxygen Levels - What Happens During Exercise? (Masks in Exercise - a RandomIsed Trial)
A study testing cloth mask, surgical mask and FFP2 respirator in people with Impact of Masks on Oxygen Levels, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The investigators aim to determine the effect of three different types of face mask compared to no face mask on the oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The three face masks will be a cloth mask, a surgical mask and a FFR. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impact of Masks on Oxygen Levels
- What is being tested?
- cloth mask, surgical mask and FFP2 respirator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Jun 2021to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female, aged 18 - 35 years old.
- Exercise at least three times a week on a regular basis.
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Known to have a significant acute or longstanding medical illness that limits their exercise capacity.
- Develop symptoms of anosmia, cough or fever between agreeing to participate and completing the exercise, suggesting they may have developed COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Oxygen Saturations Among Healthy Young Adults Wearing Face Masks Whilst Exercising
The investigators aim to determine the effect of three different types of face mask compared to no face mask on the oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The three face masks will be a cloth mask, a surgical mask and a FFR.
Read the detailed description
The investigators will conduct a crossover study comparing three different types of face mask (cloth, surgical or filtering facepiece respirator - FFR) versus no face mask to determine the effect on oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The investigators will promote the study through sports societies at three leading United Kingdom (UK) universities, namely the University of Oxford, University of Nottingham and King's College London. The investigators will also advertise the study on social media.
Interested individuals will be encouraged to visit the study website or read the patient information sheets available to share via email. Volunteer participants will be asked to read the eligibility criteria, patient information sheet and recruitment information before applying to take part. Those who wish to participate will be asked to complete an online form, including their first name, date of birth, address, email address, demographics, details of their regular exercise and details of any past medical history or medication.
Those wishing to discuss the study will have the opportunity to request a phone call from a member of the study team before agreeing to take part.
Submitted applications will be screened by the study team for eligibility. Those who are deemed not to be eligible will be contacted, explaining the reason. Selected participants will be informed and contacted to arrange a date for the study session. This will be conducted at their local university sports centre or a local park. The number of participants attending a single study session will be in compliance with any UK government restrictions relating to COVID-19 in place at that time.
On the day of the study, participants will meet a member of the study team, who will ask them to complete an online consent form.
Participants will then be asked to complete an exercise study session. The type of exercise will be either:
- Running
- Cycling
- Rowing on a fixed machine
Participants will be asked to complete four x 15 minute pieces of exercise within this single session. The aim will be to exercise at moderate to high intensity with the goal of covering the same distance each time. Between 15 minutes of exercise, participants will be asked to take a 5 minute rest break. For each 15 minute session, participants will wear one of the following:
- a cloth mask
- a surgical mask
- a FFR
- no mask
The order in which participants wear the face masks will be determined by a random sequence generator(https://www.phc.ox.ac.uk/research/technology-outputs/sortition-clinical-trial-randomisation-software). The masks will be provided by the researcher at the time.
Participants will wear no mask during each rest period. Prior to starting, participants will have their resting heart rate and oxygen levels recorded. Halfway through each exercise period, immediately on completing the exercise and at 1 minute following completion of the exercise, participants will have their heart rate, oxygen levels and distance travelled recorded by a member of the study team.
Upon completion of the exercise session, participants will be asked to complete an online survey via a secure portal, hosted by the University of Oxford. They will be asked to complete questions regarding the type of exercise they did, oxygen levels and heart rate at each time point, distance travelled and average speed, and questions regarding the ease of exercise and comfort of wearing each masks, as well as any additional symptoms they might have experienced during the exercise session as a result of wearing the mask.
- Conditions
- Impact of Masks on Oxygen Levels
- Being tested
- cloth mask, surgical mask, FFP2 respirator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cloth maskDevice
Buff bandana double layer worn over nose and mouth
surgical maskDevice
standard surgical mask
FFP2 respiratorDevice
filtering facepiece 2 respirator
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Each participant is his/her own control. Each will have all four interventions in random order. Receives: Device: cloth mask; Device: surgical mask; Device: FFP2 respirator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation
Oxygen saturation using pulse oximeter
Measured: Immediately after exercise
Secondary outcomes (3)
heart rate
Heart rate
Measured: immediately after exercise
distance traveled
distance traveled as a % of distance traveled when unmasked
Measured: immediately after exercise
comfort
symptom survey of mask comfort and any adverse effects
Measured: immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start19 Jun 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impact of Masks on Oxygen LevelsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant is own control. Each participant will undergo all four interventions in random order.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932226
- Sponsor's protocol ID
- PHC_facemasks&exercise1
- Acronym
- MERIT
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be placed on a website
Publications
Jones N, Oke J, Marsh S, Nikbin K, Bowley J, Dijkstra HP, Hobbs FR, Greenhalgh T. Face masks while exercising trial (MERIT): a cross-over randomised controlled study. BMJ Open. 2023 Jan 5;13(1):e063014. doi: 10.1136/bmjopen-2022-063014.
PubMed 36604128
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Oxygen Saturations Among Healthy Young Adults Wearing Face Masks Whilst Exercising
- ClinicalTrials.gov ID
- NCT04932226
- Acronym / sponsor ID
- MERIT / PHC_facemasks&exercise1
- Conditions
- Impact of Masks on Oxygen Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Nottingham, King's College London
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to determine the effect of three different types of face mask compared to no face mask on the oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The three face masks will be a cloth mask, a surgical mask and a FFR.
Detailed description
The investigators will conduct a crossover study comparing three different types of face mask (cloth, surgical or filtering facepiece respirator - FFR) versus no face mask to determine the effect on oxygen saturations, heart rate and symptoms of healthy young adults during 15 minutes of moderate to high intensity exercise. The investigators will promote the study through sports societies at three leading United Kingdom (UK) universities, namely the University of Oxford, University of Nottingham and King's College London. The investigators will also advertise the study on social media.
Interested individuals will be encouraged to visit the study website or read the patient information sheets available to share via email. Volunteer participants will be asked to read the eligibility criteria, patient information sheet and recruitment information before applying to take part. Those who wish to participate will be asked to complete an online form, including their first name, date of birth, address, email address, demographics, details of their regular exercise and details of any past medical history or medication.
Those wishing to discuss the study will have the opportunity to request a phone call from a member of the study team before agreeing to take part.
Submitted applications will be screened by the study team for eligibility. Those who are deemed not to be eligible will be contacted, explaining the reason. Selected participants will be informed and contacted to arrange a date for the study session. This will be conducted at their local university sports centre or a local park. The number of participants attending a single study session will be in compliance with any UK government restrictions relating to COVID-19 in place at that time.
On the day of the study, participants will meet a member of the study team, who will ask them to complete an online consent form.
Participants will then be asked to complete an exercise study session. The type of exercise will be either:
- Running
- Cycling
- Rowing on a fixed machine
Participants will be asked to complete four x 15 minute pieces of exercise within this single session. The aim will be to exercise at moderate to high intensity with the goal of covering the same distance each time. Between 15 minutes of exercise, participants will be asked to take a 5 minute rest break. For each 15 minute session, participants will wear one of the following:
- a cloth mask
- a surgical mask
- a FFR
- no mask
The order in which participants wear the face masks will be determined by a random sequence generator(https://www.phc.ox.ac.uk/research/technology-outputs/sortition-clinical-trial-randomisation-software). The masks will be provided by the researcher at the time.
Participants will wear no mask during each rest period. Prior to starting, participants will have their resting heart rate and oxygen levels recorded. Halfway through each exercise period, immediately on completing the exercise and at 1 minute following completion of the exercise, participants will have their heart rate, oxygen levels and distance travelled recorded by a member of the study team.
Upon completion of the exercise session, participants will be asked to complete an online survey via a secure portal, hosted by the University of Oxford. They will be asked to complete questions regarding the type of exercise they did, oxygen levels and heart rate at each time point, distance travelled and average speed, and questions regarding the ease of exercise and comfort of wearing each masks, as well as any additional symptoms they might have experienced during the exercise session as a result of wearing the mask.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant is own control. Each participant will undergo all four interventions in random order.
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Device: cloth mask, Device: surgical mask, Device: FFP2 respiratorEach participant is his/her own control. Each will have all four interventions in random order. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or Female, aged 18 - 35 years old.
- Exercise at least three times a week on a regular basis.
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (2 listed)
- Known to have a significant acute or longstanding medical illness that limits their exercise capacity.
- Develop symptoms of anosmia, cough or fever between agreeing to participate and completing the exercise, suggesting they may have developed COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cloth maskBuff bandana double layer worn over nose and mouth | Device | All participants |
| surgical maskstandard surgical mask | Device | All participants |
| FFP2 respiratorfiltering facepiece 2 respirator | Device | All participants |
Primary outcome
Oxygen saturation
Time frame: Immediately after exercise
Oxygen saturation using pulse oximeter
3 secondary outcomes
heart rate
Time frame: immediately after exercise
distance traveled
Time frame: immediately after exercise
comfort
Time frame: immediately after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Derived from this study: PubMed 36604128Jones N, Oke J, Marsh S, Nikbin K, Bowley J, Dijkstra HP, Hobbs FR, Greenhalgh T. Face masks while exercising trial (MERIT): a cross-over randomised controlled study. BMJ Open. 2023 Jan 5;13(1):e063014. doi: 10.1136/bmjopen-2022-063014.
- Individual participant dataSharing planned: Yes. Will be placed on a website
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cloth mask, surgical mask and FFP2 respirator in people with Impact of Masks on Oxygen Levels, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation (time frame: Immediately after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.