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

NCT04618991 | Completed

• 1 other identifier: APHP201080
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Score of the Quebec Sleep Questionnaire (QSQ)

  at 1 year

• Polysomnography

  at 3 months

• Epworth scale

  at 1 year

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

  at 1 year

Study Arms (1)

Adult patients with SAHOS for whom maxillary transversal surgery

EXPERIMENTAL

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

Other: Filling the Quebec Sleep Questionnaire

Interventions

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.

Adult patients with SAHOS for whom maxillary transversal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients
• With obstructive sleep apnea confirmed by polysomnography
• Surgical indication for surgically maxillary expansion

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service d'ORL, Hôpital Saint Antoine

Paris, 75013, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Boris Petelle

  Assistance Publique - Hôpitux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 6, 2020
• Study Start: March 15, 2021
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)