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Effect of HIFU on Sleep Quality Measures in Obese Doubled Chin Women

Effect of HIFU on Sleep Quality Measures in Obese Doubled Chin Women

Recruiting
35-50 years
Female
Phase N/A

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Overview

This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.

Description

PURPOSE

This study will be conducted to demonstrate any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women.

BACKGROUND

High-intensity focused ultrasound (HIFU) therapy is becoming more familiar in medical field because it is non-invasive technique with fewer side effects and provides promising therapeutic results. Several HIFU therapy applications have approved by many approval authorities of deferent countries since last decade.

HIFU cauterizes tissue from outside the body by focusing ultrasonic waves from a transducer with many ultrasonic sources on a single point, known as the target tumor .This modality is groundbreaking because it only causes coagulative necrosis via thermal and non-thermal energy (mainly cavitation) to the focal area, with hardly any impact on the intervening tissue outside the focal area.

Central obesity is significant predictor of metabolic syndrome and is associated with an increased risk of many medical conditions, including cardiovascular diseases (CVD), stroke , type 2 diabetes mellitus, hypertension , various types of cancer (e.g. colorectum, pancreas, endometrium, and breast) and all-cause mortality

Hypotheses of the study(Null) There is no significant effect of High Intensity Focused Ultrasound on sleep quality measures in obese doubled chin women.

Statement of the problem:

Is there any effect of high intensity focused ultrasound on sleep quality measures in obese doubled chin women?

Eligibility

Inclusion Criteria:

  • All patients that will be included in this study will meet the following criteria:
    1. Female subjects with age ranged from 35 to 50 years old.
    2. BMI will be 30-39.9. Class I,II

BMI was classified into six groups:

        underweight (<18.5 kg/m2) normal (18.5-24.9 kg/m2) pre-obesity (25-29.9 kg/m2) obesity
        class I (30-34.9 kg/m2) obesity class II (35-39.9 kg/m2) obesity class III (>40 kg/m2) 3.
        Clinically and medically stable. 4. Able to understand the requirements of the study.
        5.Thyroxin normal level( thyroid-stimulating hormone) (0.35 and 5.0milli-International
        unit( mIU/L)
        Exclusion Criteria:
        - The potential participants will be excluded if they meet one of the following criteria:
          1. Neurological conditions (e.g., stroke history, Parkinson's disease).
          2. Presence of an acute illness.
          3. Renal and Hepatic diseases.
          4. Patient undergoes chemotherapy.
          5. Recent surgery.
          6. Any contraindications for using HIFU such as:pregnancy ,metal prosthesis or
             implants,epilepsy,diabetes, autoimmune conditions,heart diseases including
             pacemaker,thrombosis .
        8-BMI less than 30 and more than 39.9. 9-Age less than 35 and more than 50. 10-Male
        subjects.

Study details
    OBESITY

NCT06217445

Cairo University

29 January 2024

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