Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement

Официальное название

Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through

Обзор

The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).

Подробное описание

ROHMA is a pilot/single intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.

Вмешательства

• Устройство Mandibular advancement device (MAD)
  The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.

Первичные конечные точки

• Proportion of responders [Срок оценки: through study completion on average 8 weeks]

Вторичные конечные точки (9)

• Magnitude of change in apnea-hypopnea index (AHI). [Срок оценки: through study completion on average 8 weeks]
• Change in Oxygen desaturation index (ODI) [Срок оценки: through study completion on average 8 weeks]
• Change in the time spent below oxygen saturation 90% [Срок оценки: through study completion on average 8 weeks]
• Changes in the mean arterial oxygen saturation (SaO2) [Срок оценки: through study completion on average 8 weeks]
• Adherence to MAD use [Срок оценки: through study completion on average 8 weeks]
• Change in Epworth Sleepiness Scale (ESS) [Срок оценки: through study completion on average 8 weeks]
• Epworth Sleepiness Scale (ESS) improvement [Срок оценки: through study completion on average 8 weeks]
• Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) [Срок оценки: through study completion on average 8 weeks]
• Clinical Global Impression of Improvement (CGI-I) Scale [Срок оценки: through study completion on average 8 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years.
• Ability to read, write, speak, and understand English.
• Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.
• Ability to insert and remove the mandibular advancement device (MAD) independently.
• Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).
• Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.
• Access to an internet-connected device (phone, tablet, or laptop) with a camera.

Критерии исключения

• Age over 70 years.
• Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.
• Prior intolerance to MAD therapy.
• Previous participation in a trial involving the use of oral appliances.
• Chronic nasal obstruction.
• Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.
• Insomnia and/or use of medications to treat insomnia.
• Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders.
• Substance abuse.
• Unstable psychiatric disorders.
• Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.

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

Другое

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Публикации

• Skirko JR, James KT, Garrison LP, Weaver EM. Development of a Sleep Apnea-Specific Health State Utility Algorithm. JAMA Otolaryngol Head Neck Surg. 2020 Mar 1;146(3):270-277. doi: 10.1001/jamaoto.2019.4469. PMID 31999308
• Wojda M, Kostrzewa-Janicka J, Sliwinski P, Bielen P, Jurkowski P, Wojda R, Mierzwinska-Nastalska E. Mandibular Advancement Devices in Obstructive Sleep Apnea Patients Intolerant to Continuous Positive Airway Pressure Treatment. Adv Exp Med Biol. 2019;1150:35-42. doi: 10.1007/5584_2018_275. PMID 30255301
• Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935/1984-0063.20200056. PMID 34381578
• Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11. PMID 26380759
• Woo HJ, Lim JH, Ahn JC, Lee YJ, Kim DY, Kim HJ, Rhee CS, Won TB. Characteristics of Obstructive Sleep Apnea Patients With a Low Body Mass Index: Emphasis on the Obstruction Site Determined by Drug-Induced Sleep Endoscopy. Clin Exp Otorhinolaryngol. 2020 Nov;13(4):415-421. doi: 10.21053/ceo.2019.00794. Epub 2020 Apr 29. PMID 32344992
• Wong SJ, Luitje ME, Karelsky S. Patterns of Obstruction on DISE in Adults With Obstructive Sleep Apnea Change With BMI. Laryngoscope. 2021 Jan;131(1):224-229. doi: 10.1002/lary.28777. Epub 2020 Jun 8. PMID 32511760
• Lv R, Liu X, Zhang Y, Dong N, Wang X, He Y, Yue H, Yin Q. Pathophysiological mechanisms and therapeutic approaches in obstructive sleep apnea syndrome. Signal Transduct Target Ther. 2023 May 25;8(1):218. doi: 10.1038/s41392-023-01496-3. PMID 37230968
• Kazemeini E, Van de Perck E, Dieltjens M, Willemen M, Verbraecken J, Op de Beeck S, Vanderveken OM. Critical to Know Pcrit: A Review on Pharyngeal Critical Closing Pressure in Obstructive Sleep Apnea. Front Neurol. 2022 Feb 22;13:775709. doi: 10.3389/fneur.2022.775709. eCollection 2022. PMID 35273554

Идентификаторы

NCT: NCT07132307 · 202504015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗