Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03532828
• Other study ID #: Dysmorphie / SAS
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Laboratoire de Biomécanique Georges Charpak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dentofacial Deformities
• Posture
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• polysomnography
Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform

Locations

Country	Name	City	State
France	Laboratoire de biomécanique Georges CHarpak	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire de Biomécanique Georges Charpak

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in Cephalometric analysis	Lateral cephalograms are recorded before and after surgery	Baseline, 1 year
Secondary	Change Polygraphy criteria description	Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery	Baseline, 1 year
Secondary	Change in Dentofacial deformities description	Clinical evaluation before and after surgery	Baseline, 1 year