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क्लिनिकल ट्रायल NCT07495423 के लिए Sleep Disorder (Disorder), मूड विकार वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
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Exploring the Efficacy of a Breathing Training Intervention in Patients With Emotionally Regulated Sleep Disorders 188

सक्रिय, भर्ती नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07495423 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो Sleep Disorder (Disorder), मूड विकार से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 11 जुलाई 2024 को हुई थी, और इसमें कुल 188 प्रतिभागियों के नामांकन की योजना है। Qilu Hospital of Shandong University इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 जून 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 27 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
Sleep Disorder (Disorder)मूड विकार
प्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:
अन्य अध्ययन आईडी
  • 293688
NCT नंबर
NCT07495423
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-07-11
अंतिम अद्यतन प्रकाशित
2026-03-27
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-06-01
नामांकन (अनुमानित)
188
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Insomnia
Breathing exercises
heart rate variability
mood disorder
autonomic nervous system
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
प्रयोगात्मकconventional 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...और दिखाएँ
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
भागीदारी सहायक
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
  • 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).
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Qilu Hospital of Shandong University, Jinan, Shandong, 266700, China