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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disturbances
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Dietary supplement: Lactium

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wafaa sh Elbeltagy, bachelor; Phone Number: 00201003802132; Email: wafaashaaban13march@gmail.com

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt
      • Wafaa shaaban hassan elbeltagy
      • Contact: Wafaa Shaaban Elbeltagy, Bachelor; Phone Number: 00201003802132; Email: wafaashaaban13march@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; TENS Application	Device: 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.; Dietary supplement: 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
Experimental: Group 2; Lactium	Dietary supplement: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of estradiole plasma level	by biochemical examination of estradiole plasma level	After 3 months of treatment
Change of sleep quality	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.	After 3 months of treatment

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: fayez f Elshamy, professor, kafrelshekh university

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 31, 2025
• First Submitted That Met QC Criteria: October 31, 2025
• First Posted (Estimated): November 4, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: KFSIRB200-765

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes