Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT07224295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'TENS (Frequency 80 \\_100 Hz), (Pulse duration: 150-200 μs, Pain-free stimulation intensity), (Duration;30 min)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2025-10-31', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of estradiole plasma level', 'timeFrame': 'After 3 months of treatment', 'description': 'by biochemical examination of estradiole plasma level'}, {'measure': 'Change of sleep quality', 'timeFrame': 'After 3 months of treatment', 'description': 'By assesment of the global pittsburgh sleep quality index scores a self-rated sleep questionnaire, were used to measure the quality of sleep. There are seven different parts that add up to a total of 19 questions. The scores range from 0 (no difficulty) to 3 (severe difficulty). The components include subjective sleep quality, sleep latency, length, and normal efficiency of sleep; they also include sleep disruptions, use of sleep medications, and dysfunction during the day. The seven component scores are also added together to create a global Pittsburgh Sleep Quality Index score, which ranges from 0 to 21. A score of more than 5 indicates a clinical sleep disability.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Disturbances']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to asses the effect of non invasive stellate ganglion disrupting on sleep distyrbances on postmenopausal female .\n\nThe primary hypothesis:\n\nThere is no effect of noninvasive stellate ganglion disrupting on sleep disturbance parameters of postmenopausal women.\n\nThere is no effect of noninvasive stellate ganglion disrupting on quality of female's life\n\nNon invasive stellate ganglion disrupting with physical modality TENS will be applied on participants of study group. The participants will be screened for estradiol level and assed for the quality of sleep by specialized questionnaire.", 'detailedDescription': 'This study will be conducted on 32 postmenopausal women referred by physicians having sleep disturbances. They will be recruited from kafr el-zayat General Hospital, El-gharbia Governorate, Egypt.\n\nAll participants will be given a full explanation of the protocol of the study and informed consent form will be signed from each subject before participating in this study. The protocol will be sent for approval the ethical committee of the faculty of Physical Therapy kafrelshekh University.\n\nThe subjects will be divided randomly into two groups equal in number, study group (group A) and control group (group B):\n\n* Study group (group A): This group will consist of sixteen women complaining from sleep disturbance with post menopause who will receive TENS (Frequency 80 \\_100 Hz), (Pulse duration: 150-200 μs, Pain-free stimulation intensity), (Duration;30 min).\n* Control group (group B): This group will consist of sixteen women complaining from sleep disturbance with post menopause.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Post menopausal female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. postmenopausal women who are firstly have sleep disturbances.\n2. Their ages will range from 50- 65 years old.\n3. All patients will be medically stable when attending the study.\n4. BMI≥30.\n\nExclusion Criteria:\n\n\\-\n\nWomen will be excluded from study if:\n\n1. Women with Impaired consciousness.\n2. Inability to communicate with the paramedic because of insufficient language skills.\n3. receiving any medication for sleep disturbances.\n4. Patients who already have sleep disturbances due to another pathological reason or taking any medications which directly affect sleep.\n5. Patients with psychological diseases.\n6. Women who have any cancer diseases.\n7. Diabetic and patient with cardiovascular disease.'}, 'identificationModule': {'nctId': 'NCT07224295', 'briefTitle': 'The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female', 'orgStudyIdInfo': {'id': 'KFSIRB200-765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'TENS Application', 'interventionNames': ['Device: Transcutaneous Electrical Nerve Stimulation (TENS)', 'Dietary Supplement: Lactium']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Lactium', 'interventionNames': ['Dietary Supplement: Lactium']}], 'interventions': [{'name': 'Transcutaneous Electrical Nerve Stimulation (TENS)', 'type': 'DEVICE', 'description': "TENS (Frequency 80 \\_100 Hz), (Pulse duration: 150-200 μs, Pain-free stimulation intensity), (Duration;30 min) On one side of the patient's neck, at the location of the stellate ganglion, we positioned two adhesive 25 mm to administer the TENS treatment, while the other side remained untreated. Of the two adhesive electrodes, one was placed near to the paravertebral location in the region of the trapezius muscle on its base near the sixth cervical transverse process, and the other in the region of the stellate ganglion in the supraclavicular aspect (Fig. 2). To obtain a stellate ganglion disrupting, we used a dual-channel TENS stimulator.", 'armGroupLabels': ['Group 1']}, {'name': 'Lactium', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactium is a natural milk protein hydrolysate that contains a bioactive decapeptide called alpha-casozepine, which has natural relaxing and calming properties. It is used as a dietary supplement ingredient to help manage symptoms of stress, anxiety, and sleep disorders.this supplement will be taken once daily', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Elgharbia', 'country': 'Egypt', 'contacts': [{'name': 'Wafaa Shaaban Elbeltagy, Bachelor', 'role': 'CONTACT', 'email': 'wafaashaaban13march@gmail.com', 'phone': '00201003802132'}], 'facility': 'Wafaa shaaban hassan elbeltagy', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'wafaa sh Elbeltagy, bachelor', 'role': 'CONTACT', 'email': 'wafaashaaban13march@gmail.com', 'phone': '00201003802132'}], 'overallOfficials': [{'name': 'fayez f Elshamy, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kafrelshekh university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior physical therapist', 'investigatorFullName': 'Wafaa Shaaban Hassan Elbeltagy', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}