SnorkelingNCT04783688
Evaluation of Full Face Snorkel Masks (FFSMs)
A study testing Full Face Snorkel Mask (FFSM) in people with Snorkeling and Face Mask Squeeze, run by Duke University at 1 site in United States.
Trial summary
Recently, multiple models of Full Face Snorkel Mask (FFSM) have entered the retail market. However, several fatalities have been reported to the non-profit agency Divers Alert Network (DAN) for snorkelers who were using FFSMs, and most of these fatality reports have unclear or unreported causes of death. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Snorkeling, Face Mask Squeeze, Underwater Physiology
- What is being tested?
- Full Face Snorkel Mask (FFSM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 11 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Preferred >35 years old
- Safe to perform light activity
- Age 18-40
- VO2max exercise test results >30 mL/kg/min for female, >35 mL/kg/min for male
Who cannot join
- Subjects must NOT be certified SCUBA divers
- GROUP B:
- Subjects must NOT be certified SCUBA divers
- May not be active smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Center for Hyperbaric Medicine & Environmental Physiology
Durham, North Carolina, 27710
About this study
Official title: Evaluation of a Full Face Snorkel Mask (FFSM)
Recently, multiple models of Full Face Snorkel Mask (FFSM) have entered the retail market. However, several fatalities have been reported to the non-profit agency Divers Alert Network (DAN) for snorkelers who were using FFSMs, and most of these fatality reports have unclear or unreported causes of death. This project is to determine the characteristics of the FFSMs when they are in use by snorkelers. Volunteers will be asked to snorkel in a water tank while breathing through several models of commercially available FFSM, one at at time.
Read the detailed description
The scientific testing will take place in the water tank of Foxtrot chamber at the Duke Center for Hyperbaric Medicine \& Environmental Physiology. This Center (referred to as "Duke Hyperbarics") has a long history of testing various aspects of undersea physiology and causes of injury and death. Duke Hyperbarics will conduct the physical tests, and DAN (Divers Alert Network) personnel will also supervise the scientific testing.
The experimental test subjects will be divided into two categories. Before testing, both categories will come in for a screening day, where they will go through the informed consent process and be medically screened for safety to perform activity. For the first category of subjects (Group A), five volunteer subjects will be recruited with no restrictions on age or fitness level. An effort will be made to include representative test subjects from older age ranges (>35 years old) in this group. To ensure they can safely perform light activity, they will be screened for cardiovascular disease, both by questionnaire and by a physical exam during the screening day.
The second group (Group B) will be age 18-40, non-smoking, and screened for fitness using a physical exam and a VO2max test. The reason for these two groups is to ensure that a spectrum of test subjects is examined across the comprehensive range of ages and fitness levels that may participate in snorkeling as recreation.
The testing will be designed to assess the function of the FFSMs produced by multiple brands compared to each other as well as compared to conventional snorkels. Test subjects will be positioned horizontally in warm water. They will be face-down on a bicycle ergometer, grasping handlebars for stability. On the test day, each subject will undergo three test procedures, using first a conventional snorkel then two different brands of FFSM while pedaling the underwater bicycle. Group A will be asked to pedal at a rate that is comfortable for them, while Group B will be given a targeted higher work rate to achieve.
For each FFSM test, the test subject will be asked to place the mask on themselves but provided no further instruction. The pressure exerted by the mask on the forehead will also be measured by placing a small, flexible, force-sensitive gauge between the skirt and the skin (this gauge needs to be in place for only a few seconds and will be removed before snorkeling). At the end of each test, the subjects will be asked to remove the FFSM quickly in response to an audible or visual alarm that will appear three times at randomized intervals. Their ability to remove the masks quickly will be timed.
- Being tested
- Full Face Snorkel Mask (FFSM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Face Snorkel Mask (FFSM)Other
A mask used for snorkeling that covers the entire face, as opposed to a conventional snorkel, which is held in the mouth only.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | All subjects will snorkel using the same FFSMs. Receives: Other: Full Face Snorkel Mask (FFSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional level of oxygen in the breathing gas (at steady state) provided by the different mask models
The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.
Measured: Estimated 4 hours long
Fractional level of carbon dioxide in the breathing gas (at steady state) provided by the different mask models
The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.
Measured: Estimated 4 hours long
Secondary outcomes (1)
Speed of removal of the different FFSM models
The speed at which subjects can remove the different models of FFSM will be timed and measured in seconds for comparison between models.
Measured: Estimated 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start9 Mar 2021
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnorkelingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study is a measurement of subjects performing normal tasks in a controlled environment, with physiological measurements
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Divers Alert Network
- Responsible party
- Sponsor
- Investigators
- Rachel Lance, PhD, Principal investigator, Duke University Health System, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783688
- Sponsor's protocol ID
- Pro00106241
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Processed, anonymized experimental results will be shared with Divers Alert Network (DAN).
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Full Face Snorkel Mask (FFSM)
- ClinicalTrials.gov ID
- NCT04783688
- Acronym / sponsor ID
- Pro00106241
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Divers Alert Network
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 5 Mar 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.
Recently, multiple models of Full Face Snorkel Mask (FFSM) have entered the retail market. However, several fatalities have been reported to the non-profit agency Divers Alert Network (DAN) for snorkelers who were using FFSMs, and most of these fatality reports have unclear or unreported causes of death. This project is to determine the characteristics of the FFSMs when they are in use by snorkelers. Volunteers will be asked to snorkel in a water tank while breathing through several models of commercially available FFSM, one at at time.
Detailed description
The scientific testing will take place in the water tank of Foxtrot chamber at the Duke Center for Hyperbaric Medicine \& Environmental Physiology. This Center (referred to as "Duke Hyperbarics") has a long history of testing various aspects of undersea physiology and causes of injury and death. Duke Hyperbarics will conduct the physical tests, and DAN (Divers Alert Network) personnel will also supervise the scientific testing.
The experimental test subjects will be divided into two categories. Before testing, both categories will come in for a screening day, where they will go through the informed consent process and be medically screened for safety to perform activity. For the first category of subjects (Group A), five volunteer subjects will be recruited with no restrictions on age or fitness level. An effort will be made to include representative test subjects from older age ranges (>35 years old) in this group. To ensure they can safely perform light activity, they will be screened for cardiovascular disease, both by questionnaire and by a physical exam during the screening day.
The second group (Group B) will be age 18-40, non-smoking, and screened for fitness using a physical exam and a VO2max test. The reason for these two groups is to ensure that a spectrum of test subjects is examined across the comprehensive range of ages and fitness levels that may participate in snorkeling as recreation.
The testing will be designed to assess the function of the FFSMs produced by multiple brands compared to each other as well as compared to conventional snorkels. Test subjects will be positioned horizontally in warm water. They will be face-down on a bicycle ergometer, grasping handlebars for stability. On the test day, each subject will undergo three test procedures, using first a conventional snorkel then two different brands of FFSM while pedaling the underwater bicycle. Group A will be asked to pedal at a rate that is comfortable for them, while Group B will be given a targeted higher work rate to achieve.
For each FFSM test, the test subject will be asked to place the mask on themselves but provided no further instruction. The pressure exerted by the mask on the forehead will also be measured by placing a small, flexible, force-sensitive gauge between the skirt and the skin (this gauge needs to be in place for only a few seconds and will be removed before snorkeling). At the end of each test, the subjects will be asked to remove the FFSM quickly in response to an audible or visual alarm that will appear three times at randomized intervals. Their ability to remove the masks quickly will be timed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study is a measurement of subjects performing normal tasks in a controlled environment, with physiological measurements
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Full Face Snorkel Mask (FFSM)All subjects will snorkel using the same FFSMs. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preferred >35 years old
- Safe to perform light activity
- Age 18-40
- VO2max exercise test results >30 mL/kg/min for female, >35 mL/kg/min for male
Key exclusion criteria (4 listed)
- Subjects must NOT be certified SCUBA divers
- Subjects must NOT be certified SCUBA divers
- May not be active smokers
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 |
|---|---|---|
| Full Face Snorkel Mask (FFSM)A mask used for snorkeling that covers the entire face, as opposed to a conventional snorkel, which is held in the mouth only. | Other | Experimental Group |
Primary outcome
Fractional level of oxygen in the breathing gas (at steady state) provided by the different mask models
Time frame: Estimated 4 hours long
The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.
Fractional level of carbon dioxide in the breathing gas (at steady state) provided by the different mask models
Time frame: Estimated 4 hours long
The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.
1 secondary outcome
Speed of removal of the different FFSM models
Time frame: Estimated 20 minutes
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 14 Jul 2021.
- Individual participant dataSharing planned: No. Processed, anonymized experimental results will be shared with Divers Alert Network (DAN).
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.
Rachel Lance, PhD principal investigator
Duke University Health System, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Face Snorkel Mask (FFSM) in people with Snorkeling and Face Mask Squeeze, run by Duke University at 1 site in United States.
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 4 inclusion and 4 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 14 Jul 2021. 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 States. 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?
Fractional level of oxygen in the breathing gas (at steady state) provided by the different mask models (time frame: Estimated 4 hours long). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.