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Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

Primary Purpose

Dentofacial Deformities, Sleep Disorder, Posture

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polysomnography
Sponsored by
Laboratoire de Biomécanique Georges Charpak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dentofacial Deformities

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratoire de biomécanique Georges CHarpak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Polysomnography alone

Polysomnography and postural assesment

Arm Description

A polygraphy will be performed in 70 patient to search for obstructive sleep apnea

A polygraphy and a postural assesment will be performed in 30 patients

Outcomes

Primary Outcome Measures

Change in 2D displacement range of the pressure center
Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery

Secondary Outcome Measures

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
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
Change in Cephalometric analysis
Lateral cephalograms are recorded before and after surgery
Change Polygraphy criteria description
Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery
Change in Dentofacial deformities description
Clinical evaluation before and after surgery

Full Information

First Posted
April 10, 2018
Last Updated
May 11, 2023
Sponsor
Laboratoire de Biomécanique Georges Charpak
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1. Study Identification

Unique Protocol Identification Number
NCT03532828
Brief Title
Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients
Official Title
Nocturnal Respiratory Disorders Identification and Their Influence on the Body Posture and Breathing Synchronisation in Patients With Dentofacial Dysgnathia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire de Biomécanique Georges Charpak

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentofacial Deformities, Sleep Disorder, Posture

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polysomnography alone
Arm Type
Experimental
Arm Description
A polygraphy will be performed in 70 patient to search for obstructive sleep apnea
Arm Title
Polysomnography and postural assesment
Arm Type
Experimental
Arm Description
A polygraphy and a postural assesment will be performed in 30 patients
Intervention Type
Other
Intervention Name(s)
polysomnography
Other Intervention Name(s)
Postural evaluation
Intervention Description
Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform
Primary Outcome Measure Information:
Title
Change in 2D displacement range of the pressure center
Description
Pressure center is recorded with force plates 1month before and 1 year after orthognathic surgery
Time Frame
Baseline, 1 year
Secondary Outcome Measure Information:
Title
Change in EOS criteria description
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
Time Frame
Baseline, 1 year
Title
Change Stabilometric criteria description
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
Time Frame
Baseline, 1 year
Title
Change in Cephalometric analysis
Description
Lateral cephalograms are recorded before and after surgery
Time Frame
Baseline, 1 year
Title
Change Polygraphy criteria description
Description
Apnea-hypopnea index, oxygen saturation , before and after orthognathic surgery
Time Frame
Baseline, 1 year
Title
Change in Dentofacial deformities description
Description
Clinical evaluation before and after surgery
Time Frame
Baseline, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Laboratoire de biomécanique Georges CHarpak
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Interaction Between Body Posture and Nocturnal Sleeping Disorders in Dysgnathic Patients

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