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
- Interventions
- Other: Filling the Quebec Sleep Questionnaire
- Registration Number
- NCT04618991
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Adult patients
- With obstructive sleep apnea confirmed by polysomnography
- Surgical indication for surgically maxillary expansion
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adult patients with SAHOS for whom maxillary transversal surgery Filling the Quebec Sleep Questionnaire Adult patients with SAHOS for whom maxillary transversal surgery is recommended.
- Primary Outcome Measures
Name Time Method Score of the QSQ at 3 months Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.
- Secondary Outcome Measures
Name Time Method Epworth scale at 1 year Epworth scale score changes before and after surgery
correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data at 1 year correlation between the results of the QSQ score and the anthropometric data
Score of the Quebec Sleep Questionnaire (QSQ) at 1 year Score of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery.
Polysomnography at 3 months Search for a modification of the polysomnography data before and after surgery
Trial Locations
- Locations (1)
Service d'ORL, Hôpital Saint Antoine
🇫🇷Paris, France