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

March 22, 2026 updated by: Qilu Hospital of Shandong University
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 266700
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
After 2 weeks, 1 month, 2 months, and 3 months
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.
After 2 weeks, 1 month, 2 months, and 3 months
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 (%).
After 2 weeks, 1 month, 2 months, and 3 months
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.
After 2 weeks, 1 month, 2 months, and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
After 2 weeks, 1 month, 2 months, and 3 months
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).
After 2 weeks, 1 month, 2 months, and 3 months
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).
After 2 weeks, 1 month, 2 months, and 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months
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.
after 2 weeks, after 1 month, after 2 months, after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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