Clinical trial NCT06217445: Effect of HIFU on Sleep Quality Measures in Obese Doubled Chin Women
Official title: Effect of High Intensity Focused Ultrasound on Sleep Quality Measures in Obese Doubled Chin Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: OBESITY
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel study is type of clinical study in which two or more groups of participants receive different interventions.
Primary purpose: TREATMENT

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

Detailed 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 criteria: 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.

Primary outcomes:
measure: submental fat scale
timeFrame: 3 months
measure: Spirometric assessment for obesity
timeFrame: 3 months
measure: Impact of Weight on Quality of Life Assessment Tools:
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of hormonal changes
timeFrame: 3 months
measure: Assessment of snoring
timeFrame: 3 months
measure: Assessment of sleep apnea:
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: HANI EZZAT OBAYA, prof ass.dr
role: STUDY_DIRECTOR
References:
citation: Ayatollahi A, Gholami J, Saberi M, Hosseini H, Firooz A. Systematic review and meta-analysis of safety and efficacy of high-intensity focused ultrasound (HIFU) for face and neck rejuvenation. Lasers Med Sci. 2020 Jul;35(5):1007-1024. doi: 10.1007/s10103-020-02957-9. Epub 2020 Feb 5.
citation: Zhou X, Li Y, Zhu Q, Luo J, Cao L, Quetai J, Li F, Tang MX, Wang Z. A Theragnostic HIFU Transducer and System for Inherently Registered Imaging and Therapy. IEEE Trans Biomed Eng. 2023 Dec;70(12):3413-3424. doi: 10.1109/TBME.2023.3287870. Epub 2023 Nov 21.