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

NCT07224295 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: KFSIRB200-765
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbances

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1

EXPERIMENTAL

TENS Application

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Dietary Supplement: Lactium

Group 2

EXPERIMENTAL

Lactium

Dietary Supplement: Lactium

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Group 1

Lactium DIETARY_SUPPLEMENT

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 1; Group 2

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: Post menopausal female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postmenopausal women who are firstly have sleep disturbances.
• Their ages will range from 50- 65 years old.
• All patients will be medically stable when attending the study.
• BMI≥30.

You may not qualify if:

• Women will be excluded from study if:
• Women with Impaired consciousness.
• Inability to communicate with the paramedic because of insufficient language skills.
• receiving any medication for sleep disturbances.
• Patients who already have sleep disturbances due to another pathological reason or taking any medications which directly affect sleep.
• Patients with psychological diseases.
• Women who have any cancer diseases.
• Diabetic and patient with cardiovascular disease.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Wafaa shaaban hassan elbeltagy

Tanta, Elgharbia, Egypt

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• fayez f Elshamy, professor

  kafrelshekh university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wafaa sh Elbeltagy, bachelor

CONTACT

00201003802132; wafaashaaban13march@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior physical therapist

Model Details: TENS (Frequency 80 \_100 Hz), (Pulse duration: 150-200 μs, Pain-free stimulation intensity), (Duration;30 min)

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)