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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04618991
Acronym
QUAVIMAX
Enrollment
9
Registered
2020-11-06
Start date
2021-03-15
Completion date
2023-10-31
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique

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.

Interventions

OTHERFilling 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score of the QSQat 3 monthsScore of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.

Secondary

MeasureTime frameDescription
Score of the Quebec Sleep Questionnaire (QSQ)at 1 yearScore of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery.
Polysomnographyat 3 monthsSearch for a modification of the polysomnography data before and after surgery
Epworth scaleat 1 yearEpworth scale score changes before and after surgery
correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric dataat 1 yearcorrelation between the results of the QSQ score and the anthropometric data

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026