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

The research aims to assess the impact on quality of life of surgically maxillary expansion in adult patients followed for obstructive sleep apnea syndrome.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Filling the Quebec Sleep Questionnaire

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris Petelle, MD; Phone Number: 0033 6 62 40 01 50; Email: boris.petelle@gmail.com

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Service d'ORL, Hôpital Saint Antoine
    • Contact: Boris Dr Petelle; Email: boris.petelle@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adult patients with SAHOS for whom maxillary transversal surgery; Adult patients with SAHOS for whom maxillary transversal surgery is recommended.	Other: 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.

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Boris Petelle, Assistance Publique - Hôpitux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Anticipated): April 15, 2024
• Study Completion (Anticipated): April 15, 2024

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; obstructive sleep apnea; surgically assisted rapid maxillary expansion; distraction osteogenesis; palatal expansion technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: APHP201080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No