The acute effect of aerobic exercise on sleep in patients with depression: a randomized controlled trial

This dataset will enable sharing of data collected within the EASED trial. BACKGROUND Unipolar depression is one of the most relevant mental disorders. Insomnia is a symptom of cardinal importance in depression. 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. Existing therapies for insomnia in depression have limitations. Further adjuvant therapies are therefore needed. Acute aerobic exercise has been shown to have beneficial effects on sleep in healthy individuals and patients with insomnia. We therefore hypothesize that a single bout of aerobic exercise has positive effects on sleep in patients with unipolar depression. The aim of this trial is to investigate the effects of a single bout of aerobic exercise on sleep in patients with depression. METHODS This will be a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. Patients between 18 and 65 years of age with a primary diagnosis of unipolar depression (without a psychotic episode) will be included. Exclusion criteria are regular use of hypnotic agents, opioids, and certain beta-blockers, presence of factors precluding exercise, history of epilepsy, restless legs syndrome, moderate obstructive sleep apnea and a BMI >40. The intervention is a single bout of aerobic exercise. Exercise will be performed for 30 minutes on a bicycle ergometer at 70% individual anaerobic threshold. The control group will sit and read magazines. The primary outcome is sleep efficiency measured by polysomnography. Secondary outcomes include further polysomnographic variables, subjective pre-sleep arousal, nocturnal cardiovascular autonomic tone, subjective sleep quality, daytime sleepiness, and adverse events. According to sample size calculation a total of 92 patients will be randomized using minimization. DISCUSSION This trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression. Thereby, the trial will inform decision makers on the utility of acute aerobic exercise.