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

NCT06217445 | Unknown

• 1 other identifier: HIFU treatment on obese women
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

OBESITY

Outcome Measures

Primary Outcomes (3)

• submental fat scale

  It ranges from 0 (no localised sub-mental fat) to 4 (extreme submental convexity). The ideal patient for would be someone who is a '2' or '3' on sub-mental scale, so someone with moderate to severe sub-mental fullness

  3 months

• Spirometric assessment for obesity

  patients underwent spirometry tests with measurement of forced expiratory volume in first second (FEV1), forced vital capacity (FVC)and(MVV)

  3 months

• Impact of Weight on Quality of Life Assessment Tools:

  The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is a validated, 31-item, self-report measure of obesity-specific quality of life in adults, available in multiple languages. scale structure of the IWQOL-Lite has been verified with confirmatory factor analysis, and IWQOL-Lite scores are sensitive to changes in weight. There is strong evidence for validity and reliability. ▪ In addition to a total score, there are scores on five domains: * Physical function (11 items) * Self-esteem (7 items) * Sexual life (4 items) * Public distress (5 items) * Work (4 items) Scores range from 0 to 100, with 100 representing the best quality of life. Raw scores are no longer used for reporting

  3 months

Secondary Outcomes (3)

• Assessment of hormonal changes

  3 months

• Assessment of snoring

  3 months

• Assessment of sleep apnea:

  3 months

Study Arms (2)

HIFU plus exercises

EXPERIMENTAL

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.

Device: high intensity focused ultrasound

doubled chin exercises

EXPERIMENTAL

1. Straight jaw jut 2. Ball exercise 3. Pucker up . 4. Tongue stretch 5. Neck stretch 6. Bottom jaw jut

Other: Doubled chin exercises

Interventions

high intensity focused ultrasound 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

HIFU plus exercises

Doubled chin exercises OTHER

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

doubled chin exercises

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients that will be included in this study will meet the following criteria:
• Female subjects with age ranged from 35 to 50 years old.
• 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)

You may not qualify if:

• \- The potential participants will be excluded if they meet one of the following criteria:
• Neurological conditions (e.g., stroke history, Parkinson's disease).
• Presence of an acute illness.
• Renal and Hepatic diseases.
• Patient undergoes chemotherapy.
• Recent surgery.
• Any contraindications for using HIFU such as:pregnancy ,metal prosthesis or implants,epilepsy,diabetes, autoimmune conditions,heart diseases including pacemaker,thrombosis .
• BMI less than 30 and more than 39.9. 9-Age less than 35 and more than 50. 10-Male subjects.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 12613, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 32026164 BACKGROUND

• 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.

  PMID: 37339046 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• HANI EZZAT OBAYA, prof ass.dr

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nahla tharwat mousa ahmed, ASS.LEC

CONTACT

01096254602; nahlatharwat1@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: DOUBLE BLIND
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

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

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 22, 2024
• Study Start: January 6, 2024
• Primary Completion: April 6, 2024
• Study Completion: April 6, 2024
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

EG (1)