![]() However, the number of trained specialists considerably limits access to this treatment. Cognitive behavioral therapy for insomnia (CBT-I) and pharmacotherapy are currently considered first- and second-line therapies for insomnia (regardless whether comorbidities are present or not). There is an abundance of research related to insomnia treatments. Hyperarousal can be cognitive (e.g., rumination, dysfunctional beliefs), emotional (emotional reactivity), cortical (beta activity in sleep EEG), or physiological (e.g., metabolic rate, heart rate variability). The current state of knowledge suggests that hyperarousal, as well as sleep reactivity, are core etiological factors of insomnia. ![]() Another symptom may be non-restorative sleep. Insomnia encompasses problems initiating or maintaining sleep with daytime impairments. Hence, there is a need for further adjuvant non-pharmacological treatment options. Moreover, the majority of patients tend to prefer non-pharmacological treatments for insomnia and depression. However, the STAR*D trial investigating four treatment steps in over 4000 patients concluded that only two-thirds of people treated for depression with pharmacotherapy, cognitive behavioral therapy, or both were in remission after treatment. Meta-analytic data show moderate to large effect sizes for pharmacotherapy (0.35), psychotherapy (0.37), and combined therapy (0.74) when compared to placebo. Psychotherapy, pharmacotherapy or a combination of both are the primary treatments for depression according to guidelines. There is a plethora of research concerning treatments for depression. It is also associated with lower cardiorespiratory fitness, an independent risk factor for cardiovascular mortality in healthy individuals. Depression is associated with an increased risk of comorbidities and cardiovascular mortality. Core symptoms of depression are depressed mood, anhedonia, and a lack of drive. It is projected to become the leading cause of burden of disease worldwide by 2030. Worldwide the lifetime prevalence is estimated to be between 10 and 15%. Unipolar depression is a mental disorder of paramount importance. Protocol version 1 registered on 17 September 2018. Thereby, the results will inform decision makers on the utility of acute aerobic exercise. This trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression. According to the sample size calculation, a total of 92 patients will be randomized using minimization. Secondary outcomes include further polysomnographic variables, subjective pre-sleep arousal, nocturnal cardiovascular autonomic modulation, subjective sleep quality, daytime sleepiness, and adverse events. The primary outcome is sleep efficiency measured by polysomnography. The control group sits and reads for 30 min. The intervention is a single bout of aerobic exercise, performed for 30 min on a bicycle ergometer at 80% individual anaerobic threshold. ![]() Exclusion criteria are regular use of hypnotic agents, opioids, and certain beta-blockers, as well as the presence of factors precluding exercise, history of epilepsy, restless legs syndrome, moderate obstructive sleep apnea, and a BMI > 40. Patients between 18 and 65 years of age with a primary diagnosis of unipolar depression (without a psychotic episode) are included. This is a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. This trial aims to investigate the effects of a single bout of aerobic exercise on the subsequent night’s sleep in patients with depression. We therefore hypothesize that a single session of aerobic exercise has a positive impact on sleep in patients with unipolar depression. Acute aerobic exercise has been shown to have beneficial effects on sleep in healthy individuals and patients with insomnia. Further adjuvant therapies are therefore needed. Existing therapies for insomnia in depression have limitations. It increases the risk to develop depression, negatively affects disease trajectory, is the most common symptom after remission, increases the risk of relapse, and is associated with higher suicide rates. Insomnia is a symptom of cardinal importance in depression. Unipolar depression is one of the most important mental disorders. ![]()
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