The Effect of Non Invasive Stellate Ganglion Disrupting on Sleep Disturbances on Postmenopausal Female

Not Applicable

Not yet recruiting

• Conditions: Sleep Disturbances

• Registration Number: NCT07224295
• Lead Sponsor: Kafrelsheikh University

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.

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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-31
• Study First Submitted QC: 2025-10-31
• Study First Posted: 2025-11-04
• Last Update Submitted: 2025-11-07
• Study Start: 2025-11-10
• Last Update Posted: 2025-11-10
• Primary Completion: 2026-02-10
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. postmenopausal women who are firstly have sleep disturbances.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of estradiole plasma level	After 3 months of treatment	by biochemical examination of estradiole plasma level
Change of sleep quality	After 3 months of treatment	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.

Trial Locations

Locations (1)

Wafaa shaaban hassan elbeltagy; 🇪🇬 Tanta, Elgharbia, Egypt