Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives

Официальное название

Obstructive Sleep Apnea Non-PAP Outcomes and Viable Alternatives (OSANOVA): Comparison of Mandibular Advancement Device and Hypoglossal Nerve Stimulation Outcomes

Обзор

OSANOVA is a non-randomized clinical trial which aims to compare outcomes of mandibular advancement device (MAD) and hypoglossal nerve stimulation (HGNS) therapies in moderate-to-severe OSA patients who fail, decline, or are intolerant to positive airway pressure (PAP) therapy (referred to as PAP-failing patients). The primary aim of the study is to compare the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Primary Outcome measures include changes in Pittsburgh Sleep Quality Index (PSQI) scores. Secondary aims will help us describe the outcomes between PAP-failing moderate-to-severe OSA patients receiving MAD and those receiving HGNS therapy. Secondary outcome measures include: * adverse events, * Epworth Sleepiness Scale (ESS), * Symptoms of Nocturnal Obstruction and Related Events (SNORE-25), * patient-reported satisfaction, * CGI-Improvement, * the rate of subjects re-selecting the treatment, and * the rate of subjects recommending the treatment. and * changes in sleep study metrics (i.e., AHI, ODI, mean arterial saturation, and Time\<90%),

Подробное описание

The study will enroll and follow a cohort of PAP-failing patients receiving MAD therapy and a second cohort receiving HGNS therapy. Baseline and post-intervention patient-reported outcome measures (PROMs) and standard sleep study parameters to evaluate and compare treatment efficacy will be captured.

Both MAD and HGNS are accepted treatments for moderate OSA patients following PAP intolerance, refusal, or failure. Current decision-making is based heavily on patient preference rather than well-defined evidence-based recommendations. Choosing the right therapy is a crucial aspect of treatment for OSA, a chronic and lifelong condition.

Вмешательства

• Устройство MAD
  MAD intervention involves the use of a mandibular advancement device, which is designed to reposition the lower jaw and tongue to keep the airway open during sleep.
• Устройство HGNS
  HGNS intervention involves a surgical procedure to implant a device that stimulates the hypoglossal nerve to prevent airway collapse during sleep.

Первичные конечные точки

• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: baseline(pre-treatment) and through study completion on average 8 weeks]

Вторичные конечные точки (11)

• Clinical Global Impressions-Improvement (CGI-I) [Срок оценки: through study completion on average 8 weeks]
• Epworth Sleepiness Scale (ESS) scores. [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scores. [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Measure of satisfaction with treatment [Срок оценки: and through study completion on average 8 weeks]
• The rate of subject re-selecting the treatment [Срок оценки: and through study completion on average 8 weeks]
• The rate of subjects recommending the treatment [Срок оценки: and through study completion on average 8 weeks]
• Apnea-Hypopnea Index (AHI) [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Oxygen Desaturation Index (ODI) [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Mean arterial saturation [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Time <90% [Срок оценки: baseline (pre-treatment) and through study completion on average 8 weeks]
• Adverse events [Срок оценки: throughout the entire study period on average 10 weeks]

Критерии участия

Критерии включения

• Must consent to being a part of the study
• Must be willing and able to physically present to the our office site on the Hospital campus whenever necessary over the course of the study
• Able to read, write, speak, and understand English
• Willing to complete study surveys over the course of the study.
• Must have a diagnosis for moderate to severe OSA (AHI ≥15) with indications for PAP therapy OSA is stratified into mild (5 ≤ AHI ≤ 15), moderate (15 < AHI ≤ 30), and severe (AHI>30)
• Must have declined PAP therapy (unwillingness to use), failed PAP therapy (AHI > 15 on PAP), or are inadherent to PAP therapy (not using PAP ≥4 hours/night for ≥5 nights per week, also defined as intolerance to PAP)
• Age ≥ 18 years
• BMI ≤ 40 kg/m²
• Central/Mixed apneas contribute < 25% of AHI (Predominantly Obstructive Sleep Apnea)
• Willing to complete pre-intervention and post-intervention sleep studies
• Planning to obtain MAD or HGNS as part of clinical care

Критерии исключения

• AHI > 65

o The guidelines for HGNS usage were originally approved for an AHI upper limit of 65. We will not enroll anyone in the study with an AHI greater than 65.

• Dental conditions such as temporomandibular joint disease, periodontal disease, dental disease, insufficient dentition (edentulism) to support appliance retention, and inadequate range of motion of the jaw. Similarly, patients undergoing dental realignment (e.g., braces or retaining device) are not suitable candidates.
• Chronic nasal obstruction
• Individuals without manual dexterity to place and remove the device such as those afflicted with severe arthritis, or neuromuscular disease that affects dexterity.
• Prior intolerance to MAD
• Rapid therapy required: patients in whom rapid initiation of treatment is desirable (e.g., patients with severe symptomatic OSA, sleepiness while driving) and they declined PAP without PAP failure. PAP therapy can be initiated quickly while MAD initiation requires incremental titration of the device over weeks to months to attain optimal efficacy.
• Severe or prolonged Oxygen desaturation: patients with severe oxyhemoglobin desaturation during sleep (e.g., nadir peripheral oxygen saturation \[SpO2\] <70 percent), caution is warranted as oral appliance therapy may not provide optimal improvement in oxygenation.
• Alcohol or illicit substance use at least daily
• Unstable psychiatric condition
• 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

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University — St Louis

Публикации

• Basyuni S, Barabas M, Quinnell T. An update on mandibular advancement devices for the treatment of obstructive sleep apnoea hypopnoea syndrome. J Thorac Dis. 2018 Jan;10(Suppl 1):S48-S56. doi: 10.21037/jtd.2017.12.18. PMID 29445528
• Bentan MA, Nord R. Comprehensive Analysis of Adverse Events Associated With Hypoglossal Nerve Stimulators: Insights From the MAUDE Database. Otolaryngol Head Neck Surg. 2024 Nov;171(5):1580-1590. doi: 10.1002/ohn.883. Epub 2024 Jun 29. PMID 38943447
• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. PMID 2748771
• Cistulli PA. Oral appliances in the treatment of obstructive sleep apnea in adults. In: Collop N, Finlay G, eds. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com/contents/oral-appliances-in-the-treatment-of-obstructive-sleep-apnea-in-adults. Topic 7678, Version 38.0. Accessed October 30, 2024.
• de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980. PMID 31596213
• El-Solh AA, Moitheennazima B, Akinnusi ME, Churder PM, Lafornara AM. Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study. Sleep Breath. 2011 May;15(2):203-8. doi: 10.1007/s11325-010-0437-1. Epub 2010 Nov 10. PMID 21063793
• Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76. PMID 19960649
• Francis CE, Quinnell T. Mandibular Advancement Devices for OSA: An Alternative to CPAP? Pulm Ther. 2021 Jun;7(1):25-36. doi: 10.1007/s41030-020-00137-2. Epub 2020 Nov 10. PMID 33170490

Идентификаторы

NCT: NCT07074288 · 202502149

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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