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:
Kafrelsheikh University
Organization:
Study Overview
Official Title:
The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to asses the effect of non invasive stellate ganglion disrupting on sleep distyrbances on postmenopausal female .
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.
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:
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: