Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adu… (NCT04618991) | Clinical Trial Compass
CompletedNot Applicable
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
France9 participantsStarted 2021-03-15
Plain-language summary
The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.
Who can participate
Age range
18 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:
* Adult patients
* With obstructive sleep apnea confirmed by polysomnography
* Surgical indication for surgically maxillary expansion
Exclusion Criteria:
* \- Patients refusing to participate in the survey having formulated their opposition
* Diabetes,
* Obesity (BMI\> 30)
* Failure to provide informed written consent
* Refusal or inability to return to all follow-up visits and sleep studies
* Patient pregnant or planning to become pregnant in the next 12 months or breastfeeding
* Surgical resection or radiation therapy for cancer or congenital malformations of the larynx, tongue or throat (Note that some previous surgeries, such as uvulopalatopharyngoplasty (UPPP), tonsillectomy or adenoidectomy, to remove obstructions related to obstructive sleep apnea are allowed)
* Obvious obstructions of the fixed upper airways (tumors, polyps or nasal obstruction)
* Patients who have undergone previous surgery on the mandible and / or maxilla, other than dental treatment.
* Patients included in another clinical study (excluding registers).
* Patients taking medicines such as opiates which may affect sleep, alertness or breathing
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.