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Clinical Trial NCT07495423 for Sleep Disorder (Disorder), Mood Disorders is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders 188
Clinical Trial NCT07495423 is an interventional study for Sleep Disorder (Disorder), Mood Disorders that is active, not recruiting. It started on 11 July 2024 with plans to enroll 188 participants. Led by Qilu Hospital of Shandong University, it is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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 r...Show More
Official Title
Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders
Conditions
Sleep Disorder (Disorder)Mood DisordersPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 293688
NCT ID Number
Start Date (Actual)
2024-07-11
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
188
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Insomnia
Breathing exercises
heart rate variability
mood disorder
autonomic nervous system
Breathing exercises
heart rate variability
mood disorder
autonomic nervous system
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentalconventional clinical intervention Health education and publicity for patients and their families, informing them of medication precautions, dietary guidance | 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 trai...Show More |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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
- 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).
Qilu Hospital of Shandong UniversityNo contact data.
1 Study Locations in 1 Countries
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 266700, China