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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-06

Study Completion Date

2024-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female

NCT06729203

Central Obesity

RECRUITING NA

Ultrasound Lipolysis Versus Cryolipolysis On Lipid Profile Levels In Centrally Obese Middle Aged Men

NCT06658639

Ultrasound Lipolysis Cryolipolysis Lipid Profile +1 more

NOT_YET_RECRUITING NA

Low-Frequency, High-Intensity Ultrasound for Waist Circumference Reduction

NCT04206384

Abdominal Subcutaneous Fat

COMPLETED NA

Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women

NCT05982002

Obesity

COMPLETED NA

Effects of Radiofrequency on Located Adiposity

NCT02546778

Adiposity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

OBESITY

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel study is type of clinical study in which two or more groups of participants receive different interventions.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

DOUBLE BLIND

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HIFU plus exercises

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

Group Type EXPERIMENTAL

high intensity focused ultrasound

Intervention Type DEVICE

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

doubled chin exercises

1. Straight jaw jut
2. Ball exercise
3. Pucker up

.
4. Tongue stretch
5. Neck stretch
6. Bottom jaw jut

Group Type EXPERIMENTAL

Doubled chin exercises

Intervention Type OTHER

1\. Straight jaw jut. 2-ball exercise. 3-Pucker up 4. Tongue stretch 5. Neck stretch 6-bottom jaw jut.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high intensity focused ultrasound

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

Intervention Type DEVICE

Doubled chin exercises

1\. Straight jaw jut. 2-ball exercise. 3-Pucker up 4. Tongue stretch 5. Neck stretch 6-bottom jaw jut.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No