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Набор скоро начнётся NCT07679282

A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults

Фаза IV С лечением Obstructive Sleep Apnea (OSA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Positive airway pressure (PAP) therapy, Sleep dental device, Atomoxetine-oxybutynin.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

Обзор

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Вмешательства

  • Устройство Positive airway pressure (PAP) therapy
    Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
  • Устройство Sleep dental device
    An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
  • Препарат Atomoxetine-oxybutynin
    The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Первичные конечные точки

  • Health-related quality of life [Срок оценки: At 12 months]
Вторичные конечные точки (7)
  • OSA treatment effectiveness - Effective AHI score [Срок оценки: 12 months]
  • OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a [Срок оценки: 12 months]
  • Changes in systolic blood pressure [Срок оценки: 12 months]
  • Changes in diastolic blood pressure [Срок оценки: 12 months]
  • OSA treatment adherence [Срок оценки: 12 months]
  • Adverse effects of OSA treatment [Срок оценки: 12 months]
  • Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months
  • Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness
  • Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)
  • Health insurance of any type

Критерии исключения

  • Prior treatment for OSA in past year
  • Central sleep apnea or narcolepsy
  • Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)
  • Heart failure with reduced ejection fraction of </= 45%
  • Active coronary artery disease (angina or infarction within 3 months of enrollment)
  • Current untreated depression
  • Untreated narrow angle glaucoma
  • Untreated hypothyroidism
  • Clinically significant gastric retention
  • Clinically significant urinary retention
  • History of liver disease
  • Seizure disorder
  • Pregnant or nursing, or plans to become pregnant within the year
  • Concomitant medication use that is incompatible with atomoxetine or oxybutynin
  • Participation in another clinical study with an investigational product

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 4 центра
  • Banner University Medical Center Tucson — Tucson
  • Stanford Medical Center — Palo Alto
  • University of Miami Miller School of Medicine — Miami
  • University of Maryland Medical Center — Baltimore

Публикации

  • Aishah A, Loffler KA, Toson B, Mukherjee S, Adams RJ, Altree TJ, Ainge-Allen HW, Yee BJ, Grunstein RR, Carberry JC, Eckert DJ. One Month Dosing of Atomoxetine plus Oxybutynin in Obstructive Sleep Apnea: A Randomized, Placebo-controlled Trial. Ann Am Thorac Soc. 2023 Apr;20(4):584-595. doi: 10.1513/AnnalsATS.202206-492OC. PMID 36538809
  • Taranto-Montemurro L, Messineo L, Sands SA, Azarbarzin A, Marques M, Edwards BA, Eckert DJ, White DP, Wellman A. The Combination of Atomoxetine and Oxybutynin Greatly Reduces Obstructive Sleep Apnea Severity. A Randomized, Placebo-controlled, Double-Blind Crossover Trial. Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276. doi: 10.1164/rccm.201808-1493OC. PMID 30395486
  • Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13. PMID 35551600
  • Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250. PMID 35975547
  • Kinouchi T, Terada J, Sakao S, Koshikawa K, Sasaki T, Sugiyama A, Sato S, Sakuma N, Abe M, Shikano K, Hayama N, Shiko Y, Ozawa Y, Ikeda S, Suzuki T, Tatsumi K. Effects of the combination of atomoxetine and oxybutynin in Japanese patients with obstructive sleep apnoea: A randomized controlled crossover trial. Respirology. 2023 Mar;28(3):273-280. doi: 10.1111/resp.14383. Epub 2022 Oct 2. PMID 36184258
  • Chen TY, Chung CH, Chang HA, Kao YC, Chang SY, Kuo TBJ, Yang CCH, Chien WC, Tzeng NS. Long-term atomoxetine-oxybutynin combination use may be beneficial for the prevention of obstructive sleep apnea. Sci Rep. 2021 Jun 15;11(1):12526. doi: 10.1038/s41598-021-91988-5. PMID 34131226
  • Schwartz M, Acosta L, Hung YL, Padilla M, Enciso R. Effects of CPAP and mandibular advancement device treatment in obstructive sleep apnea patients: a systematic review and meta-analysis. Sleep Breath. 2018 Sep;22(3):555-568. doi: 10.1007/s11325-017-1590-6. Epub 2017 Nov 11. PMID 29129030
  • Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858. PMID 26094920

Идентификаторы

NCT: NCT07679282 · BPS-2024C2-37819

Первоисточники (государственные реестры)

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