Ignite Creation Date:
2025-12-18 @ 9:35 AM
Ignite Modification Date:
2025-12-23 @ 11:29 PM
Study NCT ID:
NCT03796078
Status:
None
Last Update Posted:
2023-05-16 00:00:00
First Post:
2019-01-03 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
Sponsor:
None
Organization:
Study Overview
Official Title:
Impact of Maxillomandibular Advancement Upon the Pharyngeal Airway Volume and the Apnea-hypopnea Index in the Treatment of Obstructive Sleep Apnea
Status:
None
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them.
METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center.
During the study period:
* Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1).
* Assessment of PAS/PAV stability (relapse) at short term (1 month).
3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery.
* Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist)
* Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12).
* Record of body mass index (BMI) (cm/Kg2)
Main Objective:
• Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA.
Specific objectives:
• Interrelate the degree of dentofacial deformity with the IAH.
* Study the potential correlation between the volume of the VAS and the IAH.
* Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS).
* Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA.
Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA.
* To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA.
* Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA.
* Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term.
* Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery.
Hypothesis
* H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term.
* H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.
METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center.
During the study period:
* Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1).
* Assessment of PAS/PAV stability (relapse) at short term (1 month).
3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery.
* Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist)
* Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12).
* Record of body mass index (BMI) (cm/Kg2)
Main Objective:
• Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA.
Specific objectives:
• Interrelate the degree of dentofacial deformity with the IAH.
* Study the potential correlation between the volume of the VAS and the IAH.
* Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS).
* Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA.
Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA.
* To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA.
* Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA.
* Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term.
* Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery.
Hypothesis
* H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term.
* H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: