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NCT03796078
Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea
NA trial testing Maxillomandibular advancement in OSA in 80 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Centro Medico Teknon |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 30 April 2018 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 December 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Maxillomandibular advancement
- monomaxillary surgery (isolated MaxS)
- monomandibullary surgery (MandS)
Conditions studied
- OSA — all drugs for OSA →
- OSAS — all drugs for OSAS →
- Apnea, Obstructive Sleep — all drugs for Apnea, Obstructive Sleep →
- Orthognathic Surgery — all drugs for Orthognathic Surgery →
Sponsor
Centro Medico Teknon — full company profile →
Who can join
18 and older, any sex, with OSA or OSAS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03796078
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03796078 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centro Medico Teknon
- Last refreshed: 16 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03796078.
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