Clinical trial NCT04618991: Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
quality of life
surgically assisted rapid maxillary expansion
distraction osteogenesis
palatal expansion technique
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Score of the QSQ
timeFrame: at 3 months
Secondary outcomes:
measure: Score of the Quebec Sleep Questionnaire (QSQ)
timeFrame: at 1 year
measure: Polysomnography
timeFrame: at 3 months
measure: Epworth scale
timeFrame: at 1 year
measure: correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data
timeFrame: at 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'ORL, Hôpital Saint Antoine
Study officials:
affiliation: Assistance Publique - Hôpitux de Paris
name: Boris Petelle
role: STUDY_CHAIR
References: