🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07495423
Active, not recruiting Not applicable

Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders

NCT07495423 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Hospital of Shandong University
Phase
Not applicable
Started
2024-07-11
Last updated
2026-03-27

Condition(s) studied

Sleep Disorder (Disorder)Mood Disorders

Investigational drug(s) / intervention(s)

respiratory training intervention

respiratory training intervention: The study group received a two-week breathing training program in addition to routine clinical care. The program consisted of three exercises rotated daily: pursed-lip breathing involving slow exhalation through pursed lips at a 2:1 exhalation-to-inhalation ratio, practiced for 15 minutes three times daily; balloon blowing requiring patients to slowly inflate five 1000ml balloons within 15 minutes; and breathing trainer exercises where patients sat upright to perform forceful inhalations holding a ball elevated for 5 seconds, repeating 5-10 times per session. Each exercise was performed for 15 minutes three times daily, with one exercise type practiced each day in a rotating cycle completed twice weekly. All training sessions were conducted in an outpatient setting.

Study summary

In recent years, the incidence of sleep disorders, especially insomnia, has been rising. Insomnia can directly lead to damage to patients' daytime functions, such as daytime sleepiness, inattention, etc., affecting people's normal work and life. Insomnia is related to dysfunction of multiple systems such as the cardiovascular and cerebrovascular systems, endocrine systems, digestion and breathing, and plays a vital role in the occurrence and development of chronic diseases. Therefore, insomnia has become an increasingly serious medical and social problem. At the same time, with the development of society, the incidence of mental illness is gradually increasing. Emotional disorders such as anxiety and depression can greatly affect the quality of life and even seriously endanger people's health and life safety. Insomnia is closely related to mood disorders. Insomnia not only increases the patient's risk of depression, but also increases the risk of suicide in young patients. In addition, mood disorders are also closely related to insomnia. Mood disorders such as anxiety and depression will also increase the incidence of insomnia. There are also studies showing that the quality of life of patients with severe depression is related to insomnia. The impact of emotional state on sleep is multidimensional. Meneo summarized various mechanisms by which emotions affect sleep, such as dysfunction of the prefrontal cortex and amygdala, as well as factors such as cognitive behavior. Among these mechanisms, functional imbalance of the autonomic nervous system is considered to be a core link. The autonomic nervous system is mainly composed of two branches: the sympathetic nervous system and the parasympathetic nervous system. On the one hand, under conditions of emotional stress or anxiety, the activity of the sympathetic nervous system is enhanced, leading to physiological reactions such as increased heart rate and blood pressure, thereby increasing alertness and reducing the tendency to sleep. On the other hand, during sleep, the activity of the parasympathetic nervous system is enhanced, especially reflected by increasing the high-frequency component of heart rate variability, which contributes to the improvement of sleep depth and quality. Although the relationship between mood and sleep disorders has been widely recognized, current research on its underlying mechanisms is still limited, and it is difficult to develop effective intervention strategies based on this. As an emerging biological monitoring method, heart-brain co-testing can simultaneously monitor and analyze the activities of the brain and heart, interpret the connection of heart-brain axis functions from a new perspective, help elucidate related physiological activities, provide evidence for determining the mechanism of the impact of emotions on sleep disorders, and improve the accuracy of diagnosis and evaluation of the effectiveness of treatment. The mind-brain testing method plays a vital role in revealing the complex connection between emotions and sleep disorders. It is expected to improve our research on the mechanisms of emotion and sleep disorders, find new ways to intervene, and thereby improve the public's physical and mental health.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Meet the diagnostic criteria for insomnia disorder. * Be between 18 and 80 years of age, inclusive. * Have questionnaire scores indicating clinical significance: Pittsburgh Sleep Quality Index (PSQI) score \> 5 Insomnia Severity Index (ISI) score \> 7 Hamilton Anxiety Scale (HAMA) score \> 7 and/or Hamilton Depression Scale (HAMD) score ≥ 7 * Be able to communicate effectively and provide informed consent in the primary language of the study site. * Provide written informed consent prior to participation Exclusion Criteria: * Insomnia that is secondary to another underlying physical or medical condition. * A primary diagnosis of another sleep disorder (e.g., sleep apnea, restless legs syndrome) or a primary mood disorder that is considered the main cause of sleep disturbance. * Chronic sleep disturbances primarily attributable to environmental or lifestyle factors (e.g., shift work, excessive noise, childcare duties).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong

More Qilu Hospital of Shandong University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07495423 on ClinicalTrials.gov ↗ ← All trials in China