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The Effects of Atomoxetine and Trazodone Combination on Obstructive Sleep Apnea and Sleep Microstructure: A Double-Blind Randomized Clinical Trial Study Publisher Pubmed



Shahbazi M1 ; Heidari R2 ; Tafakhori A1 ; Samadi S3 ; Nikeghbalian Z4 ; Amirifard H1, 4 ; Najafi A3, 4
Authors
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Authors Affiliations
  1. 1. Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Otolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Sleep Breathing Disorders Research Center, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Occupational Sleep Research Center, Baharloo Hospital, Tehran University of Medical Sciences, Tehran, Iran

Source: Sleep Medicine Published:2024


Abstract

Study objectives: we aimed to compare the effects of atomoxetine and trazodone (A-T) in combination with placebo in patients with obstructive sleep apnea (OSA). Methods: This randomized, placebo-controlled, double-blind, crossover trial study was conducted in adults with OSA referred to a Sleep Clinic. Participants with eligibility criteria were recruited. Patients were studied on two separate nights with one-week intervals, once treated with trazodone (50 mg) and atomoxetine (80 mg) combination and then with a placebo and the following polysomnography tests. Results: A total of 18 patients with OSA completed the study protocol, 9(50%) were male, the mean age was 47.5 years (SD = 9.8) and the mean Body mass index of participants was 28.4 kg/m2 (SD = 3.4). Compared with the placebo, the A-T combination resulted in significant differences in AHI (28.3(A-T) vs. 42.7 (placebo), p = 0.025), duration of the REM stage (1.3%TST (A-T) vs. 13.1%TST (placebo), p = 0.001), and the number of REM cycles (0.8 (A-T) vs. 4.7 (placebo), p = 0.001), number of apneas (38.3 (A-T) vs. 79.3 (placebo), p = 0.011), number of obstructive apneas (37.2 (A-T) vs. 75.2 (placebo), p = 0.011), oxygen desaturation index (29.5 (A-T) vs. 42.3 (placebo), p = 0.022) and number of respiratory arousals (43.2 (A-T) vs. 68.5 (placebo), p = 0.048). This decrement effect did not change among those with a low-arousal phenotype of OSA. Conclusions: The A-T combination significantly improved respiratory events’ indices compared with placebo in patients with OSA. This combination is recommended to be assessed in a large trial. It could be an alternative for those who do not adhere to the standard available treatments for OSA. © 2023 Elsevier B.V.