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הניסוי הקליני NCT07495423 עבור Sleep Disorder (Disorder), הפרעות מצב רוח הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders 188
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07495423 הוא מחקר מסוג התערבותי עבור Sleep Disorder (Disorder), הפרעות מצב רוח, שנמצא כעת במצב פעיל, לא מגייס. המחקר התחיל ב-11 ביולי 2024 ומתוכנן לכלול 188 משתתפים. המחקר מנוהל על ידי Qilu Hospital of Shandong University וצפוי להסתיים ב-1 ביוני 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 במרץ 2026.
סיכום קצר
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...הצג עוד
כותרת רשמית
Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders
מצבים רפואיים
Sleep Disorder (Disorder)הפרעות מצב רוחפרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:מזהי מחקר נוספים
- 293688
מספר NCT
תחילת המחקר (בפועל)
2024-07-11
עדכון אחרון שפורסם
2026-03-27
סיום המחקר (מוערך)
2027-06-01
משתתפים (מתוכנן)
188
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
פעיל, לא מגייס
מילות מפתח
Insomnia
Breathing exercises
heart rate variability
mood disorder
autonomic nervous system
Breathing exercises
heart rate variability
mood disorder
autonomic nervous system
מטרה ראשית
טיפול
הקצאת טיפול
לא ישים
דגם מתערב
קבוצה יחידה
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיconventional 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...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
מתנדבים בריאים מתקבלים
כן
- 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 Universityאין נתוני קשר.
1 מיקומי המחקר ב-1 מדינות
Shandong
Qilu Hospital of Shandong University, Jinan, Shandong, 266700, China