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

Obstructive Sleep Apnea Clinical Trial

— QUAVIMAX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618991
• Other study ID #: APHP201080
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: April 15, 2024

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Boris Petelle, MD
• Phone: 0033 6 62 40 01 50
• Email: boris.petelle[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
France	Service d'ORL, Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Polysomnography	Search for a modification of the polysomnography data before and after surgery	at 3 months
Secondary	Epworth scale	Epworth scale score changes before and after surgery	at 1 year
Secondary	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