Abstract
BackgroundUnipolar depression is one of the most important 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 session of aerobic exercise has a positive impact on sleep in patients with unipolar depression. This trial aims to investigate the effects of a single bout of aerobic exercise on the subsequent night’s sleep in patients with depression.Methods/designThis is 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) are included. 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. The intervention is a single bout of aerobic exercise, performed for 30 min on a bicycle ergometer at 80% individual anaerobic threshold. The control group sits and reads for 30 min. The primary outcome is sleep efficiency measured by polysomnography. Secondary outcomes include further polysomnographic variables, subjective pre-sleep arousal, nocturnal cardiovascular autonomic modulation, subjective sleep quality, daytime sleepiness, and adverse events. According to the sample size calculation, a total of 92 patients will be randomized using minimization.DiscussionThis trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression. Thereby, the results will inform decision makers on the utility of acute aerobic exercise.Trial registrationClinicaltrials.gov, NCT03673397. Protocol version 1 registered on 17 September 2018.
Highlights
Unipolar depression is one of the most important mental disorders
This trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression
This paper presents the design and protocol for the trial according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement [67] (Additional file 1)
Summary
The goal of this two-arm parallel group, individually randomized, single-blind, controlled trial is to assess the superiority of an acute bout of aerobic exercise compared to no intervention in improving the subsequent night’s sleep efficiency in patients with a primary diagnosis of depression. The main limitation of this trial is the restricted polysomnographic EEG montage. The restricted EEG montage will help to recruit the necessary number of patients in an adequate period in this clinical setting. Chronic aerobic exercise is included in sleep hygiene recommendations, there is uncertainty concerning the acute effects of aerobic exercise on sleep in patients with depression. This trial aims to close this gap in the literature as well as to help the increasing number of patients with depression. All items of the World Health Organization Trial Registration Data Set can be found in the ClinicalTrials.gov registration This is the first version of the protocol, i.e., we have made no amendments. Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
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