Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

Обзор

This study looks at how jaw surgery called maxillomandibular advancement with counterclockwise rotation affects breathing during sleep in people with moderate to severe obstructive sleep apnea who cannot tolerate standard treatments such as Continous Positive Airway pressure treatment. The participants are followed over time to see whether the surgery improves sleep apnea symptoms, daytime sleepiness, and airway size, and whether these improvements last. Advanced three-dimensional imaging and airflow analysis are used to better understand how the surgery changes the airway and breathing. The goal is to evaluate the long-term effectiveness and safety of this surgical treatment.

Вмешательства

• Процедура Maxillomandibular advancement surgery with counterclockwise rotation
  Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy

Первичные конечные точки

• Apnea Hypopnea Index (AHI/h) [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]

Вторичные конечные точки (7)

• Upper airway volume [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]
• Airway velocity [Срок оценки: Registration presurgically and at 3 months, 2 years and at 5 years post operatively.]
• Epworth Sleepiness Scale (ESS) [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]
• Blood pressure [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]
• Quality of Life (QoL), Short Form-36 Health Survey [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]
• Quality of Life (QoL), Oral Health Impact Profile - Swedish version [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]
• Quality of Life (QoL), Jaw Function Limitation Scale. [Срок оценки: Registration presurgically and at 3 months, 2 years and 5 years post operatively]

Критерии участия

Критерии включения

• Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.
• Residence and/or registration in Dalarna County
• Body mass index (BMI; kg/m\^2) between 15 and 35
• Documented failure of CPAP or mandibular advancement therapy.

Критерии исключения

• Medical conditions contraindicating general anesthesia.
• American Society of Anesthesiologists Physical Status (ASA) Class III-VI
• Central sleep apnea
• Narcolepsy
• Prior orthognathic surgery
• History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include;
• Hypothyroidism
• Acromegaly
• Diabetes mellitus
• Active generalized rheumatoid arthritis
• Clinically manifest periodic limb movement disorder
• Restless legs syndrome.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Falu Hospital — Falun

Идентификаторы

NCT: NCT07446634 · 2013/125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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