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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)

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Filling the Quebec Sleep Questionnaire
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service d'ORL, Hôpital Saint AntoineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adult patients with SAHOS for whom maxillary transversal surgery

Arm Description

Adult patients with SAHOS for whom maxillary transversal surgery is recommended.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Polysomnography
Search for a modification of the polysomnography data before and after surgery
Epworth scale
Epworth scale score changes before and after surgery
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

Full Information

First Posted
October 15, 2020
Last Updated
October 28, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04618991
Brief Title
Assessment of the Impact on the Quality of Life of Surgically Assisted Maxillary Expansion in Adult Patients Followed for Obstructive Sleep Apnea Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, quality of life, surgically assisted rapid maxillary expansion, distraction osteogenesis, palatal expansion technique

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adult patients with SAHOS for whom maxillary transversal surgery
Arm Type
Experimental
Arm Description
Adult patients with SAHOS for whom maxillary transversal surgery is recommended.
Intervention Type
Other
Intervention Name(s)
Filling the Quebec Sleep Questionnaire
Intervention Description
Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.
Primary Outcome Measure Information:
Title
Score of the QSQ
Description
Score of the QSQ filled directly by the patient before surgery, compared to that then 3 months after surgery.
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Score of the Quebec Sleep Questionnaire (QSQ)
Description
Score of the QSQ filled directly by the patient before surgery, compared to that then 1 year after surgery.
Time Frame
at 1 year
Title
Polysomnography
Description
Search for a modification of the polysomnography data before and after surgery
Time Frame
at 3 months
Title
Epworth scale
Description
Epworth scale score changes before and after surgery
Time Frame
at 1 year
Title
correlation between the results of the Quebec Sleep Questionnaire (QSQ) score and the anthropometric data
Description
correlation between the results of the QSQ score and the anthropometric data
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Petelle, MD
Phone
0033 6 62 40 01 50
Email
boris.petelle@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Petelle
Organizational Affiliation
Assistance Publique - Hôpitux de Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Service d'ORL, Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boris Dr Petelle
Email
boris.petelle@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

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

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