Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia

The role of head posture has been demonstrated in patient with dentofacial deformities. However, the relationship between body posture and jaw disorders is unclear. Moreover, patients with obstructive sleep apnea have the same anatomical abnormalities than patients with dentofacial deformities. The aim of this study is to evaluate, firstly, nocturnal sleeping disorders among patients with jaw disorders. Secondly, the investigators aim to evaluate the interaction between body posture, breathing and dentofacial deformities.

A polygraphy will be performed on patient with dentofacial deformities before and after correcting jaw surgery. A postural evaluation will be done using EOS imaging system and a force plate

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disorder; Posture; Dentofacial Deformities
• Intervention / Treatment: Other: polysomnography

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Laboratoire de biomécanique Georges CHarpak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patient in orthodontic preparation for a surgical treatment,
• age > 16 years

Exclusion Criteria:

• postural disorder (scoliosis, history of spine surgery),
• pregnancy or breastfeeding,
• patients under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polysomnography alone; A polygraphy will be performed in 70 patient to search for obstructive sleep apnea	Other: polysomnography; Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform; Other Names: Postural evaluation
Experimental: Polysomnography and postural assesment; A polygraphy and a postural assesment will be performed in 30 patients	Other: polysomnography; Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform; Other Names: Postural evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 2D displacement range of the pressure center	Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery	Baseline, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EOS criteria description	Criteria: pelvic tilt, cervical lordosis, C7 sagittal vertical axis, T1 slope thoracic kyphosis, lumbar lordosis , pelvic incidence, sacral slope. 1month before and 1 year after orthognathic surgery	Baseline, 1 year
Change Stabilometric criteria description	2D displacement of the pressure center according to the anteroposterior axis, the lateral axis. 2D displacement speed. 1month before and 1 year after orthognathic surgery	Baseline, 1 year
Change in Cephalometric analysis	Lateral cephalograms are recorded before and after surgery	Baseline, 1 year
Change Polygraphy criteria description	Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery	Baseline, 1 year
Change in Dentofacial deformities description	Clinical evaluation before and after surgery	Baseline, 1 year

Collaborators and Investigators

• Sponsor: Laboratoire de Biomécanique Georges Charpak

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Sleep Wake Disorders; Dentofacial Deformities
• Other Study ID Numbers: Dysmorphie / SAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No