Reboxetine for Sleep Apnoea After ENT Surgery

Официальное название

Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study

Обзор

This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.

Вмешательства

• Препарат Reboxetine 4 MG Oral Tablet
  7 nightly doses (4mg) to commence after surgery.
• Препарат Placebo
  7 nightly doses to commence after surgery.

Первичные конечные точки

• Treatment protocol adherence [Срок оценки: 7 days]
• Data capture efficiency [Срок оценки: 14 days]

Вторичные конечные точки (11)

• Oxygen desaturation index (ODI) [Срок оценки: 14 days]
• nadir SpO2 [Срок оценки: 14 days]
• Time spent below 90% SpO2 [Срок оценки: 14 days]
• mean SpO2 [Срок оценки: 14 days]
• Sleep duration [Срок оценки: 14 days]
• Sleep efficiency (%) [Срок оценки: 14 days]
• Daytime sleepiness [Срок оценки: 14 days]
• Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire [Срок оценки: 14 days]
• Insomnia Severity Score [Срок оценки: 14 days]
• Apnoea-hypopnea hndex (AHI) [Срок оценки: 14 days]
• Study enrolment rate [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age >18 years
• Undergoing elective upper airway surgery
• History of obstructive sleep apnoea (OSA)

Критерии исключения

• Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)
• History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia
• Poorly controlled hypertension
• Epilepsy
• History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria
• History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
• Narrow angle glaucoma

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Австралия · 1 центр

• Flinders, Private and Public Hospitals and Flinders University — Bedford Park

Публикации

• Opperer M, Cozowicz C, Bugada D, Mokhlesi B, Kaw R, Auckley D, Chung F, Memtsoudis SG. Does Obstructive Sleep Apnea Influence Perioperative Outcome? A Qualitative Systematic Review for the Society of Anesthesia and Sleep Medicine Task Force on Preoperative Preparation of Patients with Sleep-Disordered Breathing. Anesth Analg. 2016 May;122(5):1321-34. doi: 10.1213/ANE.0000000000001178. PMID 27101493
• Chan MTV, Wang CY, Seet E, Tam S, Lai HY, Chew EFF, Wu WKK, Cheng BCP, Lam CKM, Short TG, Hui DSC, Chung F; Postoperative Vascular Complications in Unrecognized Obstructive Sleep Apnea (POSA) Study Investigators. Association of Unrecognized Obstructive Sleep Apnea With Postoperative Cardiovascular Events in Patients Undergoing Major Noncardiac Surgery. JAMA. 2019 May 14;321(18):1788-1798. doi: 10. PMID 31087023
• Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Gro PMID 32925318
• Altree TJ, Eckert DJ. Obstructive sleep apnea endotypes and their postoperative relevance. Int Anesthesiol Clin. 2022 Apr 1;60(2):1-7. doi: 10.1097/AIA.0000000000000357. No abstract available. PMID 35125480
• Chung F, Liao P, Yegneswaran B, Shapiro CM, Kang W. Postoperative changes in sleep-disordered breathing and sleep architecture in patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):287-98. doi: 10.1097/ALN.0000000000000040. PMID 24158049
• Chung F, Memtsoudis SG, Ramachandran SK, Nagappa M, Opperer M, Cozowicz C, Patrawala S, Lam D, Kumar A, Joshi GP, Fleetham J, Ayas N, Collop N, Doufas AG, Eikermann M, Englesakis M, Gali B, Gay P, Hernandez AV, Kaw R, Kezirian EJ, Malhotra A, Mokhlesi B, Parthasarathy S, Stierer T, Wappler F, Hillman DR, Auckley D. Society of Anesthesia and Sleep Medicine Guidelines on Preoperative Screening and A PMID 27442772
• Liao P, Luo Q, Elsaid H, Kang W, Shapiro CM, Chung F. Perioperative auto-titrated continuous positive airway pressure treatment in surgical patients with obstructive sleep apnea: a randomized controlled trial. Anesthesiology. 2013 Oct;119(4):837-47. doi: 10.1097/ALN.0b013e318297d89a. PMID 24195872
• Altree TJ, Chung F, Chan MTV, Eckert DJ. Vulnerability to Postoperative Complications in Obstructive Sleep Apnea: Importance of Phenotypes. Anesth Analg. 2021 May 1;132(5):1328-1337. doi: 10.1213/ANE.0000000000005390. PMID 33857975

Идентификаторы

NCT: NCT05978505 · 2023/HRE00060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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