An interventional study of respiratory training intervention in Sleep Disorder (Disorder) and Mood Disorders, sponsored by Qilu Hospital of Shandong University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's planned enrollment of 188 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Health education and publicity for patients and their families, informing them of medication precautions, dietary guidance
Behavioral: 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.
Sleep Onset Latency
Time from lights-off to objectively defined sleep onset determined by sleep staging using the SOMNOmedics HST device, reported in minutes.
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Wake After Sleep Onset
Total duration of wakefulness occurring after sleep onset during the night, reported in minutes.
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Sleep Efficiency
Percentage of total sleep time relative to total time in bed during overnight monitoring, reported as a percentage (%).
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Total Sleep Time
Total duration of sleep recorded during overnight monitoring using the SOMNOmedics HST device, reported in minutes.
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Low-Frequency Power of Heart Rate Variability
Low-frequency power component of heart rate variability measured using 24-hour ambulatory electrocardiography, reflecting combined sympathetic and parasympathetic activity, reported in milliseconds squared (ms²).
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
High-Frequency Power of Heart Rate Variability
High-frequency power component of heart rate variability measured using 24-hour ambulatory electrocardiography, primarily reflecting parasympathetic (vagal) activity, reported in milliseconds squared (ms²).
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Standard Deviation of Normal-to-Normal Intervals
Standard deviation of normal-to-normal (NN) R-R intervals derived from 24-hour ambulatory electrocardiography as a time-domain measure of overall heart rate variability, reported in milliseconds (ms).
Time frame: After 2 weeks, 1 month, 2 months, and 3 months
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality, latency, efficiency, disturbances, medication use, and daytime dysfunction with a total score ranging from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Insomnia Severity Index
The Insomnia Severity Index (ISI) evaluates the severity of insomnia, distress, and impact on daytime functioning, scoring from 0 to 28, with higher scores indicating more severe insomnia.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) covers attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation, with a total score from 0 to 30, lower scores suggesting worse cognitive function.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Mini-Mental State Examination (MMSE)
The Mini-Mental State Examination (MMSE) assesses orientation, memory, attention, calculation, recall, and language, with a total score from 0 to 30, lower scores indicating worse cognitive function.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAMA) measures anxiety's somatic and psychological symptoms, scoring from 0 to 56, with higher scores indicating more severe anxiety symptoms.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HAMD) evaluates depressive symptoms across mood, cognition, physical, and behavioral aspects, with a total score from 0 to 52, higher scores indicating more severe depressive symptoms.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
The Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) assesses daytime sleepiness, scoring from 0 to 24, with higher scores indicating more severe sleepiness.
Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months
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Qilu Hospital of Shandong University