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Recruiting NCT05978505

Reboxetine for Sleep Apnoea After ENT Surgery

Phase II Interventional Sleep Apnea, Obstructive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reboxetine 4 MG Oral Tablet, Placebo.
Who it may be relevant to
Registry conditions: Sleep Apnea, Obstructive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Treatment protocol adherence [Time frame: 7 days]
  • Data capture efficiency [Time frame: 14 days]
Secondary outcome measures (11)
  • Oxygen desaturation index (ODI) [Time frame: 14 days]
  • nadir SpO2 [Time frame: 14 days]
  • Time spent below 90% SpO2 [Time frame: 14 days]
  • mean SpO2 [Time frame: 14 days]
  • Sleep duration [Time frame: 14 days]
  • Sleep efficiency (%) [Time frame: 14 days]
  • Daytime sleepiness [Time frame: 14 days]
  • Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire [Time frame: 14 days]
  • Insomnia Severity Score [Time frame: 14 days]
  • Apnoea-hypopnea hndex (AHI) [Time frame: 14 days]
  • Study enrolment rate [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Other

Study locations

Australia · 1 center
  • Flinders, Private and Public Hospitals and Flinders University — Bedford Park

Publications

  • 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

Identifiers

NCT: NCT05978505 · 2023/HRE00060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗