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

NCT07495423 | Active Not Recruiting

• 1 other identifier: 293688
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorder (Disorder); Mood Disorders

Keywords

Insomnia; Breathing exercises; heart rate variability; mood disorder; autonomic nervous system

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Low-Frequency Power of Heart Rate Variability

  After 2 weeks, 1 month, 2 months, and 3 months

• High-Frequency Power of Heart Rate Variability

  After 2 weeks, 1 month, 2 months, and 3 months

• Standard Deviation of Normal-to-Normal Intervals

  After 2 weeks, 1 month, 2 months, and 3 months

• Pittsburgh Sleep Quality Index (PSQI)

  after 2 weeks, after 1 month, after 2 months, after 3 months

• The Insomnia Severity Index

  after 2 weeks, after 1 month, after 2 months, after 3 months

Study Arms (1)

conventional clinical intervention

EXPERIMENTAL

Health education and publicity for patients and their families, informing them of medication precautions, dietary guidance

Behavioral: respiratory training intervention

Interventions

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.

conventional clinical intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 266700, China

Location

Related Publications (2)

• 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.

  PMID: 32366866 RESULT

• 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.

  PMID: 38853521 RESULT

MeSH Terms

Conditions

Sleep Wake Disorders; Mood Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were divided into two groups. The intervention group received a breathing training program consisting of three exercises: Pursed-lip breathing: Inhale through the nose with the mouth closed, then exhale slowly through pursed lips (inhale:exhale ratio of 1:2). Balloon blowing: Inflate five 1000ml balloons in 15 minutes, ensuring slow and steady exhalation. Breathing trainer: Sit upright, exhale slowly, then inhale forcefully to raise a ball in the device, hold for 5 seconds, and repeat 5-10 times. Each exercise was performed for 15 minutes, three times daily, with one exercise type per day in rotation for two weeks. The control group received routine care, including health education, medication guidance, and dietary advice.

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 27, 2026
• Study Start: July 11, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)