CompletedNot Applicable

Normative Assessment of Adaptable Mouthguards.

France14 participantsStarted 2011-09-09

Plain-language summary

The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject aged 18 to 35, * Subject affiliated to a social security, * Subject who has signed the free and informed consent form. Exclusion Criteria: * Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting\> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism, * Subject under B-mimetic drug treatment, * Subject under safeguard of justice, * Subject participating in another search, * Subject during pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Impact on ventilatory flow rate by minute

Timeframe: At Week 51

Impact on O2 consumption

Timeframe: At Week 51

Impact on respiratory rate

Timeframe: At Week 51

Impact on current volume

Timeframe: At Week 51

Impact on CO2 production

Timeframe: At Week 51

Impact on comfort according an analogical visual scale for 11 criteria

Timeframe: At Week 51

Impact on electromyographic recording

Timeframe: At Week 52

Trial details

NCT IDNCT04056559

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-06-29

View on ClinicalTrials.gov More Oral Manifestations trials

Who can participate

Age range

18 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Impact on ventilatory flow rate by minute

Timeframe: At Week 51

Impact on O2 consumption

Timeframe: At Week 51

Impact on respiratory rate

Timeframe: At Week 51

Impact on current volume

Timeframe: At Week 51

Impact on CO2 production

Timeframe: At Week 51

Impact on comfort according an analogical visual scale for 11 criteria

Timeframe: At Week 51

Impact on electromyographic recording

Timeframe: At Week 52