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

Overview

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.

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
• 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

Primary outcome measures

• Change of estradiole plasma level [Time frame: After 3 months of treatment]
• Change of sleep quality [Time frame: After 3 months of treatment]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

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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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Wafaa shaaban hassan elbeltagy — Tanta

Identifiers

NCT: NCT07224295 · KFSIRB200-765

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗