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

Kafrelsheikh University

Status: Not yet enrolling

Conditions: Sleep Disturbances

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07224295

KFSIRB200-765

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Group 1

Experimental group

Description:

TENS Application

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Dietary Supplement: Lactium

Group 2

Experimental group

Description:

Lactium

Treatment:

Dietary Supplement: Lactium