The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female
NCT ID: NCT07224295
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2025-11-10
2026-02-10
Brief Summary
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The primary hypothesis:
There is no effect of noninvasive stellate ganglion disrupting on sleep disturbance parameters of postmenopausal women.
There is no effect of noninvasive stellate ganglion disrupting on quality of female's life
Non 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.
Detailed Description
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All 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.
The subjects will be divided randomly into two groups equal in number, study group (group A) and control group (group B):
* 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).
* Control group (group B): This group will consist of sixteen women complaining from sleep disturbance with post menopause.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
TENS Application
Transcutaneous Electrical Nerve Stimulation (TENS)
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.
Lactium
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
Group 2
Lactium
Lactium
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
Interventions
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Transcutaneous Electrical Nerve Stimulation (TENS)
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.
Lactium
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
Eligibility Criteria
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Inclusion Criteria
2. Their ages will range from 50- 65 years old.
3. All patients will be medically stable when attending the study.
4. BMI≥30.
Exclusion Criteria
Women will be excluded from study if:
1. Women with Impaired consciousness.
2. Inability to communicate with the paramedic because of insufficient language skills.
3. receiving any medication for sleep disturbances.
4. Patients who already have sleep disturbances due to another pathological reason or taking any medications which directly affect sleep.
5. Patients with psychological diseases.
6. Women who have any cancer diseases.
7. Diabetic and patient with cardiovascular disease.
50 Years
65 Years
FEMALE
No
Sponsors
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Kafrelsheikh University
OTHER
Responsible Party
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Wafaa Shaaban Hassan Elbeltagy
Senior physical therapist
Principal Investigators
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fayez f Elshamy, professor
Role: PRINCIPAL_INVESTIGATOR
kafrelshekh university
Locations
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Wafaa shaaban hassan elbeltagy
Tanta, Elgharbia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Wafaa Shaaban Elbeltagy, Bachelor
Role: primary
Other Identifiers
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KFSIRB200-765
Identifier Type: -
Identifier Source: org_study_id