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

NCT07224295 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-25

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • fayez f Elshamy, professor · kafrelshekh university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Device
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224295 on ClinicalTrials.gov