ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07374640 के लिए स्थायी मुद्रा धारणा चक्कर, वेस्टिबुलर माइग्रेन, Chronic Dizziness वर्तमान में अभी भर्ती शुरू नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness प्रारंभिक चरण I 12 किशोरावस्था एडेप्टिव डिज़ाइन रोकथाम वर्चुअल
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 NCT07374640 का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन स्थायी मुद्रा धारणा चक्कर, वेस्टिबुलर माइग्रेन, Chronic Dizziness से जुड़ा हुआ है और यह एक प्रारंभिक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में अभी भर्ती शुरू नहीं चल रहा है। इसमें 12 प्रतिभागियों को शामिल करने की योजना है और प्रतिभागियों का नामांकन 1 मार्च 2026 से शुरू होगा। Boston Children's Hospital इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 मई 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 6 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
Both persistent postural-perceptual dizziness (PPPD) and vestibular migraine (VM) are common diagnoses in patients presenting to physicians for evaluation of vestibular symptoms such as dizziness and vertigo. Although they are most often described in the adult population, they are also common in children and adolescents with dizziness. Chronic dizziness profoundly affects quality of life, often keeping children out o...और दिखाएँ
विस्तृत विवरण
Persistent postural-perceptual dizziness (PPPD) is a chronic vestibular disorder characterized by dizziness, unsteadiness, or non-spinning vertigo exacerbated by position changes, active or passive motion, and complex or moving visual stimuli. PPPD was defined in 2017 as an addition to the International Classification of Vestibular Disorders and will be included in the next iteration of the International Classificati...और दिखाएँ
आधिकारिक शीर्षक
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
स्वास्थ्य स्थितियां
स्थायी मुद्रा धारणा चक्करवेस्टिबुलर माइग्रेनChronic Dizzinessप्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:अन्य अध्ययन आईडी
- IRB-P00041413
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2026-03
अंतिम अद्यतन प्रकाशित
2026-03-06
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-05
नामांकन (अनुमानित)
12
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
प्रारंभिक चरण I
स्थिति
अभी भर्ती शुरू नहीं
प्रमुख शब्द
Persistent Postural-Perceptual Dizziness
Vestibular Migraine
Chronic Dizziness
Virtual Reality
Biofeedback
Vestibular Migraine
Chronic Dizziness
Virtual Reality
Biofeedback
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
प्रयोगात्मकVR in conjunction with BFB, SDERP, and CBT This group will undergo virtual reality exercises in conjunction with the standard-of-care biofeedback, systematic desensitization exposure response prevention, and cognitive behavioral therapy. | आभासी वास्तविकता Application of a virtual reality headset and experience in a virtual realty environment in addition to the standard-of-care biofeedback, systematic desensitization exposure response prevention, and cognitive behavioral therapy. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Dizziness Handicap Inventory | A 25-item self-assessment that quantifies the impact of dizziness on daily functioning. The DHI measures self-perceived handicap due to dizziness in the functional, emotional, and physical domains. Higher score corresponds to a greater perceived handicap due to dizziness. | 1 year |
Nijmegen Questionnaire | A 16-item self-report questionnaire to assess hyperventilation syndrome. Participants are asked to rate the occurrence of 16 symptoms commonly associated with hyperventilation syndrome on a 5-point Likert scale (0-Never; 4-Very often). Scores range from 0 to 64, with higher score indicating worse outcome. A score greater than 23 suggests positive diagnosis of hyperventilation syndrome. | 1 year |
Pediatric Quality of Life Inventory | A 23-item inventory that measures health-related quality of life. The PedsQL consists of 4 scales: physical, emotional, social, school. Participants rate how often each item has been a problem for them within the past month on a 5-point Likert scale (0-Never; 4-Almost always). Higher score suggests lower health-related quality of life. | 1 year |
Fear of Pain Questionnaire | A 23 or 24-item (depending on self-report or parent-proxy version) questionnaire that assesses pain-related fears. Participants are asked to rate each item on a 5-point Likert scale (0-Strongly Disagree; 4-Strongly Agree). Higher score suggests a higher level of pain-related fears. | 1 year |
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure | An 8-item self-report measure that screens for an quantifies the severity of anxiety symptoms. Participants rate the frequency of each item within the past seven days on a 5-point Likert scale (1-Never; 5-Almost always). A higher score suggests a higher severity of anxiety. | 1 year |
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Measure | An 8-item self-report measure that screens for and quantifies the severity of depression symptoms. Participants rate the frequency of each item within the past seven days on a 5-point Likert scale (1-Never; 5-Always). Higher score suggests a higher severity of depression. | 1 year |
Niigata PPPD Questionnaire | A 12-item self-reported measure intended to assess symptom severity, specifically for PPPD. Participants rate how much eat item has affected them in the past week on a 7-point Likert scale (0-None; 6-Unbearable). Scores range from 0 to 72, with higher scores indicating greater symptom severity. | 1 year |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Ratings of dizziness and pain severity, duration, and frequency | Each patient will have a "Chronic Dizziness Log" that subjectively tracks self-reported dizziness and pain associated with PPPD, including severity, duration, and frequency. Participants will be asked to report each measure on a scale of 1-10. (1-Not present; 10-As bad as it can be). | 1 year |
Degree of stress before, during, and after exposure to virtual environments | When experiencing a virtual reality (VR) environment via the VR headset, participants will be asked to report their level of stress before entering the environment, while in the environment, and after the exposure is over. Participants will be asked to report their stress on a scale of 1-10 (1-Not present; 10-As bad as it can be). | 1 year |
Degree of symptoms before, during, and after exposure to virtual environments | Each participant will be asked to report both the duration and the severity of their symptoms before entering a virtual reality environment, while experiencing that environment, and after the virtual reality exposure is over. They will be asked to report these symptom measures on a scale of 1-10 (1-Not present; 10-As bad as it can be). | 1 year |
Heart Rate Variability | A core component of biofeedback (BFB) therapy, HRV is the variation in time between each cardiac cycle, measured by ECG leads placed on the wrists and hands. This BFB measure allows researchers to track participants' progress in BFB therapy over time. HRV is expected to increase with successful treatment. | 1 year |
Respiratory Rate | A component of biofeedback (BFB) therapy, respiratory rate is the number of breaths per minute, measured by a flexible band that wraps around the participant's torso. Respiratory rate allows researchers to track participants' progress in BFB therapy. | 1 year |
Electrodermal Activity (Skin Conductance) | A component of biofeedback (BFB) therapy, electrodermal activity is the electrical conductivity of the skin, measured by small electrodes placed on the participant's fingers. Electrodermal activity allows researchers to measure the participants' progress in BFB therapy and relative level of stress/arousal. | 1 year |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क
अध्ययन के लिए न्यूनतम आयु
13 Years
अध्ययन के लिए पात्र लिंग
सभी
- Patients who previously or are currently seen in our program who have not already undergone BFB, CBT, and SDERP for treatment of their chronic dizziness.
- Patients without chronic dizziness.
- Patients for whom written consent is not available.
- Patients who exhibit psychotic features, have untreated mental health conditions, or have an intellectual disability, developmental delay, or decisional impairment.
- Non-English language preference patients.
- Patients with a history of seizures, at risk of seizures, or who have a diagnosis of epilepsy.
Boston Children's Hospitalअध्ययन उत्तरदायी पक्ष
Jacob Brodsky, मुख्य अन्वेषक, Director, Balance & Vestibular Program, Boston Children's Hospital
अध्ययन केंद्रीय संपर्क
संपर्क: Jacob R Brodsky, MD, 781-216-2849, [email protected]
संपर्क: Kyle K Pandiscio, BS, 781-216-1633, [email protected]
1 1 देशों में अध्ययन स्थान
Massachusetts
Boston Children's Hospital at Waltham, Waltham, Massachusetts, 02453, United States
Jacob R Brodsky, MD, संपर्क, 781-216-2849, [email protected]
Kyle K Pandiscio, BS, संपर्क, [email protected]