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Completed

NCT Number: NCT04618991

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'ORL, Hôpital Saint Antoine

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filling the Quebec Sleep Questionnaire

Other

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

Primary outcomes

  1. Score of the QSQ

    Time frame: at 3 months

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

Secondary outcomes

  1. Score of the Quebec Sleep Questionnaire (QSQ)

    Time frame: at 1 year

    Score of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery.

  2. Polysomnography

    Time frame: at 3 months

    Search for a modification of the polysomnography data before and after surgery

  3. Epworth scale

    Time frame: at 1 year

    Epworth scale score changes before and after surgery

  4. correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data

    Time frame: at 1 year

    correlation between the results of the QSQ score and the anthropometric data

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: QUAVIMAX

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2020
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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