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NCT Number: NCT07495423

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 266700, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

respiratory training intervention

Behavioral

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.

Primary outcomes

  1. Sleep Onset Latency

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    Time from lights-off to objectively defined sleep onset determined by sleep staging using the SOMNOmedics HST device, reported in minutes.

  2. Wake After Sleep Onset

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    Total duration of wakefulness occurring after sleep onset during the night, reported in minutes.

  3. Sleep Efficiency

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    Percentage of total sleep time relative to total time in bed during overnight monitoring, reported as a percentage (%).

  4. Total Sleep Time

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    Total duration of sleep recorded during overnight monitoring using the SOMNOmedics HST device, reported in minutes.

Secondary outcomes

  1. Low-Frequency Power of Heart Rate Variability

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    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).

  2. High-Frequency Power of Heart Rate Variability

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    High-frequency power component of heart rate variability measured using 24-hour ambulatory electrocardiography, primarily reflecting parasympathetic (vagal) activity, reported in milliseconds squared (ms²).

  3. Standard Deviation of Normal-to-Normal Intervals

    Time frame: After 2 weeks, 1 month, 2 months, and 3 months

    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).

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  5. The Insomnia Severity Index

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  6. The Montreal Cognitive Assessment

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  7. The Mini-Mental State Examination (MMSE)

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  8. The Hamilton Anxiety Scale

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  9. The Hamilton Depression Rating Scale

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    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.

  10. The Epworth Sleepiness Scale

    Time frame: after 2 weeks, after 1 month, after 2 months, after 3 months

    The Epworth Sleepiness Scale (ESS) assesses daytime sleepiness, scoring from 0 to 24, with higher scores indicating more severe sleepiness.

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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