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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-65
SponsorKafrelsheikh University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group 1Experimental treatment 2 interventions
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of estradiole plasma level

by biochemical examination of estradiole plasma level

Time frame
After 3 months of treatment
2

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.

Time frame
After 3 months of treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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