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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 (QUAVIMAX)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Other: Filling the Quebec Sleep Questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT04618991
APHP201080

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Adult patients with SAHOS for whom maxillary transversal surgery
Experimental group
Description:
Adult patients with SAHOS for whom maxillary transversal surgery is recommended.
Treatment:
Other: Filling the Quebec Sleep Questionnaire

Trial contacts and locations

1

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Central trial contact

Boris Petelle, MD

Data sourced from clinicaltrials.gov

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