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

Cairo University (CU)

Status: Enrolling

Conditions: OBESITY

Treatments: Device: high intensity focused ultrasound; Other: Doubled chin exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06217445

HIFU treatment on obese women

Details and patient eligibility

About

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

Full 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?

Enrollment: 60 estimated patients

Sex: Female

Ages: 35 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

HIFU plus exercises

Experimental group

Description:

A physician or technician first cleans the target area. They may apply a topical anesthetic cream before starting. The physician or technician then applies an ultrasound gel. The HIFU device is placed against the skin. Using an ultrasound viewer, the physician or technician adjusts the device to the right setting. Ultrasound energy is then delivered to the target area in short pulses for roughly 30 to 90 minutes. The device is removed.

Treatment:

Device: high intensity focused ultrasound

doubled chin exercises

Experimental group

Description:

Straight jaw jut Ball exercise Pucker up . Tongue stretch Neck stretch Bottom jaw jut

Treatment:

Other: Doubled chin exercises