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

NCT ID: NCT04618991

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-10-31

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Adult patients with SAHOS for whom maxillary transversal surgery

Adult patients with SAHOS for whom maxillary transversal surgery is recommended.

Group Type: EXPERIMENTAL

Filling the Quebec Sleep Questionnaire

Intervention Type: OTHER

Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.

Interventions

Filling the Quebec Sleep Questionnaire

Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Petelle

Role: STUDY_CHAIR

Assistance Publique - Hôpitux de Paris

Locations

Service d'ORL, Hôpital Saint Antoine

Paris, , France

Countries

France

Other Identifiers

APHP201080

Identifier Type: -

Identifier Source: org_study_id