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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mood Disorders; Sleep Disorder (Disorder)
• Intervention / Treatment: Behavioral: respiratory training intervention

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 266700
      • QiLU Hospital of ShanDong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: conventional clinical intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Onset Latency	Time from lights-off to objectively defined sleep onset determined by sleep staging using the SOMNOmedics HST device, reported in minutes.	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.	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 (%).	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.	After 2 weeks, 1 month, 2 months, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	after 2 weeks, after 1 month, after 2 months, after 3 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• Kuula L, Halonen R, Kajanto K, Lipsanen J, Makkonen T, Peltonen M, Pesonen AK. The Effects of Presleep Slow Breathing and Music Listening on Polysomnographic Sleep Measures - a pilot trial. Sci Rep. 2020 May 4;10(1):7427. doi: 10.1038/s41598-020-64218-7.
• Di Marco T, Scammell TE, Sadeghi K, Datta AN, Little D, Tjiptarto N, Djonlagic I, Olivieri A, Zammit G, Krystal A, Pathmanathan J, Donoghue J, Hubbard J, Dauvilliers Y. Hyperarousal features in the sleep architecture of individuals with and without insomnia. J Sleep Res. 2025 Feb;34(1):e14256. doi: 10.1111/jsr.14256. Epub 2024 Jun 9.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Insomnia; autonomic nervous system; mood disorder; Breathing exercises; heart rate variability
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Mood Disorders; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
• Other Study ID Numbers: 293688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No