Effectiveness of Non-invasive Neuromodulation Compared to Placebo on Sleep Quality in Patients With Post-COVID Symptoms: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sleep quality
研究概览
简要总结
Sleep quality and duration are critical to cognitive, emotional and physical well-being, and poor sleep quality has been associated with an increased risk of cognitive, psychological and cardiometabolic disorders. Several important physiological activities occur during sleep including a reduction in heart rate and blood pressure. In addition, sleep exerts important modulatory effects on hormone release. Previous studies have shown that lack of sleep can generate exaggerated cortisol responses or psychological and physiological stressors. Cortisol has widespread effects throughout the body and brain, affecting mood, arousal, energy, metabolic processes, and immune and inflammatory system functioning. Therefore, disruptions in cortisol secretion during the night can influence a wide variety of processes in our body that may contribute to the perception of poorer sleep quality. In addition, the salivary enzyme α-amylase is considered a biomarker of cognitive, psychosocial, emotional or physical stress. It is important to note that the autonomic nervous system (ANS) regulates several physiological processes, including heart rate, blood pressure, respiration, and digestion. The ANS consists primarily of the sympathetic system and the parasympathetic system. Increased parasympathetic activity is considered to promote health, whereas a dominant or overactive sympathetic branch is considered to be detrimental to health.
A recent study found that both sleep quality and quantity of sleep were associated with resting ANS functioning. They found that poorer sleep quality was associated with greater sympathetic dominance. Research on the sympathetic and parasympathetic branches of the ANS has shown that autonomic imbalances are precursors to disease formation and other health-related risks. Coronavirus disease 2019 (COVID-19), has in many cases involved the presence of long-lasting symptoms several weeks or months after surviving acute infection with the virus, leading to a new disease called long COVID-19 or post-COVID-19 syndrome (PCS). A recent study showed that sleep quality influences the relationship between symptoms associated with sensitization and mood disorders with health-related quality of life in people suffering from long COVID.
Non-invasive neuromodulation directed to ANS may be an option to treat the sleep disorders observed in patients with long COVID.
OBJETIVES:
Therefore, the primary objective of this study is to evaluate the efficacy of a treatment protocol on the ANS by means of non-invasive neuromodulation in aspects related to sleep in long COVID patients compared to placebo. As secondary objectives, we propose to evaluate the efficacy of a treatment protocol on the ANS by non-invasive neuromodulation in aspects related to ANS functioning, psychological variables, fatigue, pain perception and quality of life in patients with long COVID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Assignment to each group will be done by randomization software performed blindly by an external investigator who will not perform the interventions with the patients.
Assessment will be performed by two persons of the team, not involved in the treatment.
Participants will be blinded as they do not feel anything during the stimulation (whether within the active or placebo group), just the care provider will know if the cable is attached or not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with long COVID or post- acute COVID syndrome
- •With a evolution of at least 6 months after acute SARS-cov-2 infection
- •Whit symptoms present at baseline.
排除标准
- •Pregnancy.
- •Pacemakers
- •Ulcerations or wounds in the area of electrode application.
- •Decompensated heart disease.
- •Epilepsy and/or choreic syndromes.
- •Frequent medication with corticosteroids, hypnotics or supplements such as melatonin, Ashwagandha or phosphatidylserine.
- •Hypersensitivity on hands and feet that influence the use of the gloves and socks from the neuromodulation system.
研究组 & 干预措施
Non-invasive neuromodulation
The real treatment group using non-invasive neuromodulation
干预措施: Non-invasive neuromodulation (Device)
PLACEBO
The placebo treatment group (simulation of non-invasive neuromodulation application).
干预措施: Placebo (Other)
结局指标
主要结局
Sleep quality
时间窗: Baseline, at the of 15th session, at 6 month an at one year
The aspects of sleep to be assessed by means of the Pittsburgh sleep quality index (PSQI) scale and the sleep diary to be completed each morning and handed in on the last day of treatment.
次要结局
- Heart variability(Baseline and at 8 weeks)
- Cortisol and alpha amylase levels(Baseline and at 8 weeks)
- Psychological variables(Baseline, at 8 weeks, at 6 month an at one year)
- The quality of life(Baseline, at 8 weeks, at 6 month an at one year)
- Disability(Baseline, at 8 weeks, at 6 month an at one year)
- Pain intensity(Baseline, at 8 weeks, at 6 month an at one year)
研究者
Stella María Fuensalida Novo
Proffesor
Universidad Rey Juan Carlos