Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This assessment will be done using the following elements: The score of the Quebec sleep questionnaire (QSQ), developed in 2004 by Lacasse Y. et al. This questionnaire is specific to sleep apnea and may be self-administered. The main interest of this questionnaire is to measure the change in quality of life over time. The Epworth Scale Score, developed in 1991 by Murray W. John. This is a self-administered questionnaire developed to measure daytime sleepiness. Gender, age group, BMI The radiological assessment The results of polysomnography Patients will be followed for a period of 1 year and one month after surgery. The protocol visits correspond to the rhythm of post-surgery follow-up consultations in current practice. These patients are followed by Dr. Pételle at Saint-Antoine Hospital. During these visits, they will complete the Quebec sleep questionnaire and the Epworth scale, at baseline, at 3 months and then at 1 year.

Official Title
-----------------
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: Filling the Quebec Sleep Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult patients with SAHOS for whom maxillary transversal surgery<br>Adult patients with SAHOS for whom maxillary transversal surgery is recommended. | Other: Filling the Quebec Sleep Questionnaire<br>* Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the QSQ | Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery. | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the Quebec Sleep Questionnaire (QSQ) | Score of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery. | at 1 year | 
| Polysomnography | Search for a modification of the polysomnography data before and after surgery | at 3 months | 
| Epworth scale | Epworth scale score changes before and after surgery | at 1 year | 
| correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data | correlation between the results of the QSQ score and the anthropometric data | at 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique